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Amended Safety Assessment of Alkyl as Used in

Status: Tentative Amended Report for Public Comment Release Date: December 18, 2012 Panel Meeting Date: March 18-19, 2013

All interested persons are provided 60 days from the above release date to comment on this safety assessment and to identify additional published data that should be included or provide unpublished data which can be made public and included. Information may be submitted without identifying the source or the trade name of the cosmetic product containing the ingredient. All unpublished data submitted to CIR will be discussed in open meetings, will be available at the CIR office for review by any interested party and may be cited in a peer-reviewed scientific journal. Please submit data, comments, or requests to the CIR Director, Dr. F. Alan Andersen.

The 2012 Cosmetic Ingredient Review Expert Panel members are: Chairman, Wilma F. Bergfeld, M.D., F.A.C.P.; Donald V. Belsito, M.D.; Ronald A. Hill, Ph.D.; Curtis D. Klaassen, Ph.D.; Daniel C. Liebler, Ph.D.; James G. Marks, Jr., M.D., Ronald C. Shank, Ph.D.; Thomas J. Slaga, Ph.D.; and Paul W. Snyder, D.V.M., Ph.D. The CIR Director is F. Alan Andersen, Ph.D. This report was prepared by Monice M. Fiume, Senior Scientific Analyst/Writer, and Bart Heldreth, Ph.D., Chemist CIR.

Cosmetic Ingredient Review 1101 17th Street, NW, Suite 412 ♢ Washington, DC 20036-4702 ♢ ph 202.331.0651 ♢ fax 202.331.0088 ♢ [email protected]

TABLE OF CONTENTS

Abstract ...... 1 Introduction ...... 1 Chemistry ...... 1 Definition and Structure ...... 1 Methods of Manufacture ...... 1 Physical and Chemical Properties ...... 2 Impurities ...... 2 Use ...... 2 Cosmetic ...... 2 Non-Cosmetic ...... 2 Toxicokinetics ...... 3 Absorption, Distribution, Metabolism, and Excretion ...... 3 Dermal Penetration ...... 3 Penetration Enhancement ...... 3 Animal Toxicology ...... 4 Single-Dose (Acute) Toxicity ...... 4 Dermal ...... 4 Oral ...... 4 Inhalation ...... 4 Repeated-Dose Toxicity ...... 4 Oral ...... 4 Genotoxicity ...... 5 In Vitro ...... 5 In Vivo ...... 5 Carcinogenicity ...... 5 Irritation and Sensitization ...... 5 Ocular Irritation ...... 6 Miscellaneous Effects ...... 6 Dermal Effects ...... 6 Summary ...... 6 Discussion ...... 7 Conclusion ...... 8 Figures ...... 10 Figure 1. Figures ordered by chain length, chemical structure ...... 10 Tables ...... 34 Table 1. Alkyl Esters Group (presented alphabetically) ...... 34 Table 2. Conclusions (year issued) and data summaries of previously reviewed alkyl esters ...... 35 Table 3. Alkyl Esters Group (grouped by whether individual constituents have been reviewed) ...... 40 Table 4. Constituent alcohols and acids with CIR conclusions ...... 41 Table 5. Definitions and functions ...... 42 Table 6. Methods of Manufacture ...... 50 Table 7. Chemical and physical properties...... 51 Table 8. Frequency and concentration of use (historical and current) according to duration and type of exposure ...... 59 Table 9. Ingredients not reported to be in current use ...... 73 Table 10. Examples of non-cosmetic uses ...... 73 Table 11. Irritation and sensitization studies ...... 74 References ...... 77

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ABSTRACT The CIR Expert Panel assessed the safety of 239 alkyl esters for use in cosmetics, finding that these ingredients are safe in cosmetic formulations in the present practices of use and concentration when formulated to be non-irritating. The alkyl esters included in this assessment have a variety of reported functions in cosmetics, with skin conditioning agent being the most common function. The Panel reviewed available animal and clinical data in making its determination of safety on these ingredients, and, where there were data gaps, similarity in structure, properties, functions and uses of these ingredients allowed for extrapolation of the available toxicological data to assess the safety of the entire group. INTRODUCTION Cetyl esters is the International Nomenclature Cosmetic Ingredient (INCI) name for a synthetic wax composed of a mixture of esters of saturated fatty acids and fatty alcohols with carbon chain lengths between 14 and 18; this cosmetic ingredient was reviewed previously by the Cosmetic Ingredient Review (CIR) Expert Panel. In 1997, the Panel concluded that cetyl esters is safe as used in cosmetics.1 Cetyl esters is a constituent of a broader group of cosmetic ingredients, the alkyl esters, which consist of the reaction products of fatty acids and alcohols. The 239 alkyl esters being reviewed in this safety assessment are presented alphabetically in Table 1. Although 57 of these alkyl esters have been reviewed previously by the CIR Expert Panel,1-21 they are included because of their structural and functional similarities, thereby creating a complete family of alkyl esters. The conclusions reached for the previously-reviewed ingredients (including cetyl esters), along with summaries of the data included in those existing safety assessments, are provided in Table 2. The data available for these alkyl esters, which includes single-dose and repeated-dose toxicity, toxicokinetics, reproductive and developmental toxicity, genotoxicity, carcinogenicity, dermal and ocular irritation, and sensitization and photosensitization studies, support the safety of this class of cosmetic ingredients. In addition, the CIR has concluded that many of the individual constituents that make up the alkyl esters, (i.e., the alcohol and/or the acid), are safe as used in cosmetics. Because the safety of the individual constituents may be relevant to the safety of the , Table 3 indicates whether all, one, or none of the individual constituents of each alkyl esters have been found safe for use in cosmetics and Table 4 provides the conclusions reported previously for those individual components. Although the individual constituents are relevant to the safety of the alkyl esters, the available data are well-documented in the existing CIR reports and will not be summarized here; however, the maximum reported concentration of use is provided so as to reflect contextual constraints. Because the data from the existing safety assessments are included in Table 2, only new data will be included in the body of this safety assessment. CHEMISTRY Definition and Structure The ingredients in this review are alkyl esters. The core relationship between these ingredients is a carboxyl ester functional group flanked on both sides by extended alkyl chains. Some of these alkyl chains are saturated and some are unsaturated, and some of the chains are straight and some branched. (Figure 1). Formal definitions for the ingredients included in this assessment are provided in Table 5. Methods of Manufacture Most of these alkyl esters are produced synthetically via classical Fischer type esterification methods (i.e., reaction of a carboxylic acid with an alcohol to produce a carboxylic ester; Figure 2), although the reaction may be promoted by acid or base catalysis, or by the use of an acid chloride.

O O + H3C OH HO CH3 H3C O CH3 Figure 2. Synthesis of capryl caprylate from capryl alcohol and caprylic acid

However, some of the natural source ingredients in this review may be produced by transesterification (i.e., exchange of alcohol moieties to create a different ester product). For example, the triglycerides (i.e., glyceryl tri-esters) in natural oils can be reacted with alcohols to produce new monoesters (and diglycerides, monoglycerides, and glycerin, depending on reaction stoichiometry). Available methods of manufacture are summarized in Table 6.

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Physical and Chemical Properties Alkyl esters are hydrophobic materials that range from oils, at the lowest molecular weights/shortest chain-lengths, to waxy solids, at the highest molecular weights/longest chain-lengths. Physical and chemical properties data are provided in Table 7. Impurities One published reference stated that in the synthesis of oleate esters using sodium alcoholates (base catalyst), methyl oleate was the major impurity.35 (The safety assessment of decyl and isodecyl oleate includes and took into account toxicity data on methyl oleate.36) USE Cosmetic The alkyl esters are reported to function in cosmetics mostly as skin conditioning agents.37 Some of the alkyl esters are reported to have additional functions. For example, isooctyl tallate is reported to also function as a plasticizer and solvent and tetradecylpropi- onates as a solvent. However, isopropyl sorbate is reported to function as a preservative only, and not as a skin conditioning agent. The functions of each ingredient are provided in Table 5. The FDA collects information from manufacturers on the use of individual ingredients in cosmetic formulations as a function of cosmetic product category in its Voluntary Cosmetic Registration Program (VCRP). VCRP data obtained from the FDA in 201238 and data received in response to a survey of the maximum reported use concentration by category conducted by the Personal Care Products Council (Council)39,40 indicate that 113 of the 239 alkyl esters named in this safety assessment are currently used in cos- metic formulations. Ethylhexyl palmitate has the most reported uses, 1298, followed by isopropyl myristate, 1149 reported uses, and isopropyl palmitate, 999 reported uses. (Cetyl esters is reported to be used in 452 cosmetic formulations.) The results of the concentration of use survey indicate that many of the alkyl esters are used at high concentrations in cosmetic formulations. Ethyl- hexyl palmitate had the highest reported use concentration, 78% in body and hand preparations, followed by isopropyl myristate, which is used at 77.3% in other hair grooming aids and 76.6% in aerosol formulations. The frequency and concentration of use data are provided in Table 8. A number of these ingredients have been reviewed previous- ly and the historical data are included in the table. The ingredients not in use according to the VCRP and industry survey are listed in Table 9. In quite a few cases, reports of uses were received in the VCRP, but no concentration of use data are available. For example, caprylyl caprylate is reported to be used in 11 formulations, but no use concentration data were reported. Additionally, there were quite a few instances in which no reported uses were received in the VCRP, but a use concentration was provided in the industry survey. For example, oleyl linoleate was not reported in the VCRP to be in use, but the industry survey indicated that it is used in leave-on formulations at up to 11%. It should be presumed in these cases that there is at least one use in every category for which a concentration is reported. Some alkyl esters are reported to be used on baby skin, to be applied to the eye area or mucous membranes, or could possibly be ingested. Additionally, some of the alkyl esters are used in cosmetic sprays and could possibly be inhaled. Examples of some of the highest concentrations of spray uses are up to 76.6% isopropyl myristate in hair sprays, 45% ethylhexyl palmitate in indoor tanning preparations, and 23% isopropyl myristate in deodorant formulations. In practice, 95% to 99% of the droplets/particles released from cosmetic sprays have aerodynamic equivalent diameters >10 µm, with propellant sprays yielding a greater fraction of droplets/particles <10 µm compared with pump sprays.41,42 Therefore, most droplets/particles incidentally inhaled from cos- metic sprays would be deposited in the nasopharyngeal and thoracic regions of the respiratory tract and would not be respirable (i.e., they would not enter the lungs) to any appreciable amount.43,44 There is some evidence indicating that deodorant spray pro- ducts can release substantially larger fractions of particulates having aerodynamic equivalent diameters in the range considered to be respirable.44 However, the information is not sufficient to determine whether significantly greater lung exposures result from the use of deodorant sprays, compared to other cosmetic sprays. All of the alkyl esters named in this report, with the exception of behenyl olivate, cetyl myristoleate, and hexyldodecyl/octyldecyl hydroxystearate, are listed in the European Union inventory of cosmetic ingredients.45 Non-Cosmetic Isoamyl laurate and butyl stearate are approved as direct food additives for use as a flavor substance adjuvant (21CFR172.515). Many of the alkyl esters are approved as indirect food additives, as listed in the Code of Federal Regulations Title 21. Examples of non-cosmetic uses of some of the alkyl esters are provided in Table 10.

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TOXICOKINETICS Absorption, Distribution, Metabolism, and Excretion Cetyl Myristoleate Rats were fed chow containing 2% cetyl myristoleate or untreated feed for 2 h.46 No cetyl alcohol was found in the stomach, intestinal content, or mucosa in either group. (Additional details were not provided). Cetyl Oleate Groups of five male albino rats were fed a diet containing 20% cetyl oleate for 9 days; control groups were fed a fat-free diet or a diet containing 20% cottonseed oil.47 The animals were given 12 g of diet per day. The absorption of cetyl oleate was reported to be 75.3%. By day 2 of the study, the animals fed cetyl oleate developed seborrhea, which progressively increased with feeding. The animals were killed after the termination of dosing, and microscopic examination reported thickening and hyperemia of the intestinal wall. The exuded lipid was identified as cetyl oleate. The researchers stated that the absorbability and seborrhea suggested that cetyl oleate was not hydrolyzed in the gut. The researchers then dosed groups of six male rats with 2 g of cetyl oleate or an equal mixture of cetyl oleate + tributyrin by gavage, and the animals were fed a fat-free diet. Control animals were dosed with sucrose. The animals were fasted overnight on day 10 of dosing, and two animals were then killed. Two of the remaining animals were killed 1 h and two were killed 3 h after a final dose. Seborrhea was observed in both test groups; only cetyl oleate was recovered from the exuded lipid in both test groups. Intestinal weight was markedly increased in the cetyl oleate + tributyrin group. The free fatty acid content of the stomach 3 h after dosing and of the small intestine 1 and 3 h after dosing was increased in group dosed with cetyl oleate (only) when compared to controls. In the cetyl oleate + butyrin group, the free fatty acid content of the stomach was increased at both 1 and 3 h, and in the small intestine it was increased after 1 h. Dermal Penetration Isopropyl Myristate Isopropyl myristate, as a non-polar penetration enhancer, is largely retained in the stratum corneum.48 It was not detected in the receptor fluid of flow-through diffusion cells in in vitro skin permeation experiments using human epidermis (stratum corneum and viable epidermis) and dermis (varying thickness). Isostearyl Isostearate Pre-deuterated isostearyl isostearate, 7 μl/cm2, was applied neat to a 2 cm x 8 cm site on the ventral forearm of 14 human subjects for 3 h under non-occlusive conditions.49 The test site was tape-stripped 3 h after application, and attenuated total reflectance- Fourier transform infrared (ATF-FTIR) spectra measurements were determined. The researchers stated the most of the isostearyl isostearate was located at the surface of the stratum corneum. (The percent recovery of the amount applied was not specified.) Penetration Enhancement Isopropyl myristate is a non-polar penetration enhancer in pharmaceutical and cosmetic preparations. A 50:50 isopropanol- isopropyl myristate binary enhancer synergistically increased the transport of estradiol across a two-layer human epidermis in vitro.48 The average thicknesses (two donors) of the stratum corneum and viable epidermis were 14 and 60 µm, respectively. The same isopropanol-isopropyl myristate composition was used on both sides of the skin with saturated estradiol. The isopropanol- isopropyl myristate binary volume ratio varied from 0:100, 25:75, 50:50, 75:25, 100:0 isopropanol-isopropyl myristate. The per- meability coefficient was lowest for neat isopropyl myristate, increased with increasing isopropanol a 50:50 ratio was reached, and then was relatively constant as the percent of isopropanol increased. Isopropyl palmitate is reported to be used in topical formulations as a lipid layer penetration enhancer.50 The skin penetration of three lipophilic compounds (partition coefficient order: gliclazide>nimesulfide>oxaproxin) and one hydrophilic compound (ribavirin) across excised rat abdominal skin after 2 h pre-treatment with 5-20% w/w isopropyl palmitate in ethanol was deter- mined.51 All pre-treatment solutions produced a significant increase in the flux and permeation of all four compounds; the effectiveness was concentration-dependent. Skin penetration enhancement with isostearyl isostearate was evaluated in vitro using excised human abdominal skin by measuring the permeation of 5-fluorouracil through the skin after 6 h.52 Both isostearyl isostearate and the buffer control increased the rate of penetration of 5-fluorouracil, but isostearyl isostearate was not a penetration enhancer. The effect of alkyl esters on the penetration of indomethacin in vitro through excised hairless rat skin was examined.53 The perme- ation of 1% indomethacin from suspensions and from hydrogenated phospholipid gels containing cetyl caprylate, ethylhexyl pal- mitate, isocetyl palmitate, isocetyl isostearate, or isocetyl stearate was determined. The permeation rate of indomethacin from the esters increases with increased solubility of the drug in the ester. The solubility of indomethacin in liquid paraffin is very low, and there was no permeation of indomethacin from liquid paraffin after 10 h. Permeation from the isocetyl isostearate suspension, the alkyl ester indomethacin was least soluble in but with a 60-fold increase in solubility compared to liquid paraffin, was 3.8 μg/cm2 after 10 h. (Of the esters studied, indomethacin had the highest solubility in and permeation from ethylhexyl isononanoate, an 3

alkyl ester previously reviewed by the CIR, with approximately 23 μg/cm2 permeating in 10 h.) Permeation rates (and solubility) were higher in gels formed by a hydrogenated phospholipid than from suspensions. In all cases, a linear relationship existed between the cumulative amounts of indomethacin that permeated from any ester from 4 h to 10 h. In another study, the permeation rate of ketoprofen from an alkyl ester suspension through excised hairless rat skin was also proportional to its solubility in the suspension.54 ANIMAL TOXICOLOGY Single-Dose (Acute) Toxicity Dermal Butyl Oleate The dermal toxicity of butyl oleate was determined in rabbits.55 A single dose of 5 g/kg group butyl oleate was applied to the skin of 10 rabbits. Slight erythema was observed in 3 rabbits and moderate erythema in 7, and slight edema was observed in 6 rabbits and moderate edema in 3. None of the animals died, and the dermal LD50 of butyl oleate in rabbits was >5 g/kg. (Additional details were not provided). Propylheptyl Caprylate Groups of 5 male and 5 female Wistar rats were dosed dermally with a single semi-occlusive application of 0 or 2000 mg/kg bw 56 propylheptyl caprylate, applied neat. No irritation or treatment-related signs of toxicity were reported, and the dermal LD50 of propylheptyl caprylate was >2 g/kg bw. Ethylhexyl Laurate 57 The dermal LD50 of ethylhexyl laurate in rats was >3 g/kg bw. (Details were not provided). Oral Butyl Oleate 55 A group of 10 rats were dosed orally with 5 g/kg butyl oleate. None of the animals died. The oral LD50 of butyl oleate in rats was >5 g/kg. Cetyl Myristoleate 46 Five male and five female white rats were dosed orally with 5 g/kg cetyl myristoleate. There was no mortality, and the LD50 was >5 g/kg. Propylheptyl Caprylate Six female Wistar rats were dosed orally with 2 g/kg bw propylheptyl caprylate in corn oil.56 All animals had hunched posture and piloerection for 6 h after dosing, but none of the animals died during the study. The oral LD50 of propylheptyl caprylate was >2 mg/kg bw. Ethylhexyl Laurate 57 The oral LD50 of ethylhexyl laurate in rats was >2 g/kg bw. (Details were not provided). Isodecyl Laurate 58 The oral LD50 of isodecyl laurate in Wistar rats was >13 g/kg (>15 ml/kg). (Details were not provided). Inhalation Ethylhexyl Laurate 57 The inhalation LC50 of ethylhexyl laurate in rats was >230 ppm. (Details were not provided). Repeated-Dose Toxicity Oral Propylheptyl Caprylate Groups of 10 male and 10 female CD/Crl:CD(SD) rats were dosed daily by gavage with 0, 100, 300, or 1000 mg/kg bw/day propylheptyl caprylate in soybean oil for 90 days.56 No test-article related deaths occurred. No test-article related clinical signs of toxicity or changes in body weights or feed consumption, changes in the estrous cycle, or effects on sperm were observed, and there were no effects on any clinical chemistry or hematology parameters. A statistically significant decrease in the urinary pH values in males and females of the 300 and 1000 mg/kg bw/day groups was considered to be related to treatment. Absolute and relative liver weights were statistically significantly increased in animals of the high dose group. The change in urinary pH was attributed to the possibility of an acidic metabolite being eliminated in large doses, and the changes in liver weight were con- sidered a non-specific adaptive change to the liver workload at the high does, therefore, the NOAEL was established as ≥1000 mg/mg bw/day propylheptyl caprylate. 4

Ethylhexyl Laurate Male and female Sprague-Dawley rats, number per group not specified, were dosed with 0, 100, 300, or 1000 mg/kg bw ethylhexyl laurate once daily, 5 days/wk, by gavage for 28 days.57 The no-observable adverse-effect level (NOAEL) was 1000 mg/kg bw. (No additional details were provided.) Isodecyl Laurate Male Wistar rats, number per group not specified, were dosed orally with 500, 1500, or 4500 mg/kg/day isodecyl laurate, 6 days/wk, for 4 wks.58 No treatment related changes were observed at any dose level. (No additional details were provided). GENOTOXICITY In Vitro Propylheptyl Caprylate The mutagenic potential of 0.31, 0.62, 1.25, 2.5, and 5.0 μl/plate propylheptyl caprylate was evaluated in an Ames test, with and without metabolic activation, using Salmonella. typhimurium strains TA1535, TA1573, TA98, TA100, and TA102.56 Dimethyl sulfoxide served as the vehicle. Propylheptyl caprylate was not mutagenic with or without metabolic activation. An in vitro mammalian chromosomal aberration assay was performed in Chinese hamster V79 lung fibroblasts with 22.4-2480 μg/ml propylheptyl caprylate.56 The exposure time was 4 h with metabolic activation and ranged from 4-28 h without metabolic activation. Propylheptyl caprylate was not clastogenic to Chinese hamster V79 lung fibroblasts. Ethylhexyl Laurate Ethylhexyl laurate, tested at doses 8, 40, 200, 1000, and 5000 μg/plate, was not mutagenic in an Ames test performed in S. typhi- murium with and without metabolic activation.57 Isodecyl Laurate An Ames test was performed with 312-5000 μg/plate isodecyl laurate.58 Isodecyl laurate was not mutagenic towards S. typhimuri- um strains TA97, TA98, TA100, and TA102. (No additional details were provided). In Vivo Ethylhexyl Laurate A mouse micronucleus test was performed in which male and female mice were dosed by gavage with 0, 1.25, 2.5, and 5.0 ml/kg ethylhexyl laurate.57 The animals were killed after 4, 48, or 72 h. Ethylhexyl laurate was not genotoxic in this assay. CARCINOGENICITY Published carcinogenicity data were not found. IRRITATION AND SENSITIZATION Dermal irritation and sensitization studies are summarized in Table 11. Mixed results were reported in irritation testing in both non-human and human testing with some alkyl esters. In rabbits, propyl- heptyl caprylate was moderately irritating56 and ethylhexyl laurate was not irritating.57 A formulation containing 10% isopropyl palmitate was moderately irritating in male hairless guinea pigs.50 In one study in which it was unclear from the report whether the testing was done in rats or in rabbits, 30% isodecyl laurate in liquid paraffin was not a dermal irritant.58 Propylheptyl caprylate, which was moderately irritating in rabbit skin, was not irritating to human skin when applied for 48-h using an occlusive patch.56 In other clinical tests, patch testing with isopropyl myristate resulted in 3/244 positive reactions in subjects with suspected contact dermatitis59 and a formulation containing 10% isopropyl palmitate, which was moderately irritating to guinea pig skin, was well tolerated in a human chamber scarification test.50 Undiluted and 50% 2-ethylhexyl esters of C8-14 fatty acids applied openly for 60 min and 25 and 50% applied with an occlusive 24-h patch were not irritating, but undiluted 2-ethylhexyl esters of C8-14 fatty acids produced slight erythema and moderate edema when applied with an occlusive 24-h patch.57 The alkyl esters were not sensitizers in non-human or human studies. In a mouse local lymph node assay, propylheptyl caprylate did not induce a lymphocyte proliferative response, indicating that it is not a sensitizer.56 Ethylhexyl laurate57 and isodecyl laurate58 were not sensitizers in a guinea pig maximization test. In clinical testing, butyl oleate was not a sensitizer in a maximiza- tion study60 and a body oil containing 77.9% ethylhexyl palmitate,61 a containing 25.9% ethylhexyl stearate,62 an eyebrow pencil formulation containing 38.8% ethylhexyl stearate,63 a containing 29.5% isocetyl myristate,64 and a formulation containing 15.2% cetyl ricinoleate65 were not sensitizers in human repeat insult patch tests (HRIPTs).

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Ocular Irritation Propylheptyl Caprylate The ocular irritation potential of propylheptyl caprylate was evaluated in 3 female rabbits.56 Slight conjunctival irritation was observed in all animals 1 h after instillation, and the irritation had increased to a more diffuse response in one animal at 24 h after instillation. All effects subsided within 72 h for two of the animals and by 7 days in the third animal. Propylheptyl caprylate was considered slightly irritating to rabbit eyes. Ethylhexyl Laurate Ethylhexyl laurate was not irritating to rabbit eyes.57 (Details not provided). Isodecyl Laurate A study was conducted in New Zealand White rabbits to determine the ocular irritation potential of 10% isodecyl laurate in liquid paraffin.58 No significant treatment-related ocular lesions were observed. (No additional details were provided). MISCELLANEOUS EFFECTS Dermal Effects Isostearyl Isostearate A determination of skin surface water loss, measured using a plastic occlusion stress test, indicated that isostearyl isostearate (2 mg/cm2, applied neat) improved the stratum corneum water permeability barrier function.66 The researchers hypothesize that the improvement was due to effects on stratum corneum lipid phase behavior. SUMMARY Cetyl esters has been reviewed previously by the Cosmetic Ingredient Review (CIR) Expert Panel, and in 1997 the Panel conclud- ed that cetyl esters was safe as used in cosmetics. Cetyl esters is a member of a broader group of 239 cosmetic ingredients, the alkyl esters. These ingredients consist of the reaction products of fatty acids and alcohols, and the core relationship between these ingredients is a carboxyl ester functional group flanked on both sides by alkyl chains. Some of these alkyl chains are straight and some are branched. Although 57 of the alkyl esters have been reviewed previously, all are being included as ingredients in this safety assessment due to their structural and functional similarity. Ingredients included in the safety assessment are primarily re- ported to function in cosmetics as skin conditioning agents; however, isopropyl sorbate is reported to function as a preservative only. Most of these alkyl esters are produced synthetically via classical Fischer type esterification methods. However, some of the natural source ingredients in this review may be produced by transesterification. Alkyl esters are hydrophobic materials that range from oils at the lowest molecular weights/shortest chain- lengths to waxy solids at the highest molecular weights/longest chain- lengths. VCRP and industry data indicate that 113 of the 239 alkyl esters named in this safety assessment are currently used in cosmetic formulations. Ethylhexyl palmitate has the most reported uses, 1298, followed by isopropyl myristate, 1149 reported uses, and isopropyl palmitate, 999 reported uses. Ethylhexyl palmitate had the highest reported use concentration, 78% in body and hand preparations, followed by isopropyl myristate, which is used at 77.3% in other hair grooming aids and 76.6% in aerosol hair spray formulations. Isoamyl laurate and butyl stearate are approved as a direct food additives and a number of the alkyl esters are approved as indirect food additives. In rats fed a diet containing 20% cetyl oleate, absorption of cetyl oleate was reported to be 75.3%. All the animals developed seborrhea. The absorbability and seborrhea suggested that cetyl oleate was not hydrolyzed in the gut. Isopropyl palmitate is reported to be used in topical formulations as a lipid layer penetration enhancer. Isostearyl isostearate in- creased the rate of penetration of fluorouracil through excised skin, but it was not a penetration enhancer. Alkyl esters tended to increase the permeation rate of indomethacin and ketoprofen; the increase occurred due to increased solubility.

The dermal LD50 of butyl oleate in rabbits was >5 g/kg, and the dermal LD50 in rats of propylheptyl caprylate and ethylhexyl laur- ate was >2 and >3 g/kg/bw, respectively. The oral LD50 in rats was >5 g/kg for butyl oleate and for cetyl myristoleate, >2 g/kg for propylheptyl caprylate and ethylhexyl laurate, >13 g/kg for isodecyl oleate, and >64 cc/kg for isopropyl linoleate. The inhalation LC50 of ethylhexyl laurate in rats was >230 ppm. In repeated dose studies in rats, toxic effects were not observed with oral admin- istration of up to 1000 mg/kg ethylhexyl laurate or 4500 mg/kg/day isodecyl laurate for 4 wks or with up to 1000 mg/kg bw/day propylheptyl caprylate for 90 days. Propylheptyl caprylate was not mutagenic in an Ames assay (≤5.0 μl/plate) or clastogenic in an in vitro mammalian chromosomal aberration assay (≤2480 μg/ml). Ethylhexyl laurate and isodecyl laurate were not mutagenic towards S. typhimurium in an Ames assay at doses of ≤5000 μg/plate, and ethylhexyl laurate, ≤5.0 ml/kg, was not genotoxic in a mouse micronucleus test.

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Mixed results were reported in non-human irritation testing using some alkyl esters. In rabbits, propylheptyl caprylate was moderately irritating and ethylhexyl laurate was not irritating. A formulation containing 10% isopropyl palmitate was moderately irritating in male hairless guinea pigs. In one study in which it was unclear from the report whether the testing was done in rats or in rabbits, isodecyl laurate was not irritating to the skin. In a mouse local lymph node assay, propylheptyl caprylate did not induce a lymphocyte proliferative response, indicating that it is not a sensitizer. Ethylhexyl laurate and isodecyl laurate were not sensitizers in a guinea pig maximization test. Mixed irritation results were also observed in human studies. Propylheptyl caprylate, which was moderately irritating in rabbit skin, was not irritating to human skin when applied for 48-h using an occlusive patch. Patch testing with isopropyl myristate re- sulted in 3/244 positive reactions in subjects with suspected contact dermatitis. A formulation containing 10% isopropyl palmitate, which was moderately irritating to guinea pig skin, was well tolerated in a human chamber scarification test. Undiluted and 50% 2-ethylhexyl esters of C8-14 fatty acids applied openly for 60 min and 25 and 50% applied with an occlusive 24-h patch were not irritating, but undiluted 2-ethylheyxl esters of C8-14 fatty acids produced slight erythema and moderate edema when applied with an occlusive 24-h patch. No sensitization reactions were observed in human studies. Butyl oleate was not a sensitizer in a maxi- mization study and a body oil containing 77.9% ethylhexyl palmitate, a lip gloss containing 25.9% ethylhexyl stearate, an eyebrow pencil formulation containing 38.8% ethylhexyl stearate, a concealer containing 29.5% isocetyl myristate, and a lipstick formula- tion containing 15.2% cetyl ricinoleate were not sensitizers in HRIPTs. Ocular irritation studies were performed using rabbits. Cetyl esters, 60-65%, ethylhexyl laurate, 10% isodecyl laurate in liquid paraffin, and 10% isopropyl laurate in corn oil were not irritating to rabbit eyes and undiluted and 10% aq. isopropyl linoleate and propylheptyl caprylate was slightly irritating to rabbit eyes. DISCUSSION The question of whether or not a re-review of cetyl esters, an ingredient found safe as used by the Panel in 1997, was warranted was brought to the CIR Expert Panel. Although there were no new data, the inclusion of additional ingredients did warrant a re- review. As a result, the safety of the alkyl esters family is being assessed for cosmetic use; these ingredients consist of the reaction products of fatty acids and alcohols. Although there are data gaps in this report, the relatedness of molecular structures, physicochemical properties, and functions and concentrations in cosmetics allow grouping these ingredients together and interpolating the available toxicological data to support the safety of the entire group. The available data on many of the ingredients, especially the previously reviewed ingredients, and on some of the constituent alcohols and acids, are sufficient, and similar structure-property relationships, biologic characteristics, and cosmetic product usage suggest that the available data may be extrapolated to support the safety of the entire group. For example, a concern was expressed regarding the extent of dermal absorption for certain long-chain, branched alkyl esters because of a lack of information on dermal absorption and metabolism. The consensus of the Panel was that because dermal penetration of long-chain alcohols is likely to be low, and the dermal penetration for alkyl esters is likely to be even lower, inferring safety from ingredients where toxicity data were available was appropriate. The Expert Panel recognized that some of the alkyl esters can enhance the penetration of other ingredients through the skin. The Panel cautioned that care should be taken in formulating cosmetic products that may contain these ingredients in combination with any ingredients whose safety was based on their lack of dermal absorption data, or when dermal absorption was a concern. The Panel acknowledged that some of the alkyl esters may be formed from plant-derived or animal-derived acid or alcohol constit- uents. The Panel thus expressed concern regarding pesticide residues and heavy metal that may be present in botanical ingredi- ents. They stressed that the cosmetics industry should continue to use the necessary procedures to sufficiently limit amounts of such impurities in an ingredient before blending them into cosmetic formulations. Additionally, the Panel considered the dangers inherent in using animal-derived ingredients, namely the transmission of infectious agents. While tallow may be used in the manu- facture of some ingredients in this safety assessment and is clearly animal-derived, the Expert Panel notes that tallow is highly processed, and tallow derivatives even more so. The Panel agrees with determinations by the U.S. FDA that tallow derivatives are not risk materials for transmission of infectious agents. The Expert Panel was also concerned that the potential exists for dermal irritation with the use of products formulated using some of the alkyl esters. The Expert Panel specified that products must be formulated to be non-irritating. Consequently, with the use of this caveat, the data on isopropyl linoleate are now sufficient to determine safety, as follows. In a previous CIR safety assess- ment on isopropyl linoleate, the data were insufficient to determine safety for use in cosmetics; human irritation and sensitization data and genotoxicity data were needed. Because it is now stated that products containing alkyl esters must be formulated to be non-irritating, irritation and sensitization data are no longer needed. Regarding the need for genotoxicity data on isopropyl linoleate, the Panel stated that the negative genotoxicity data on a number of structurally analogous compounds mitigates that data need. The Panel also noted that although there is a lack of carcinogenicity data, the negative genotoxicity data coupled with the fact that dermal penetration is expected to be low led the Panel conclude that a request for these data was not necessary.

7

The Panel discussed the issue of incidental inhalation exposure to alkyl esters from powders and products that may be aerosolized. Some of the alkyl esters are reportedly used at up to 19% in products that may become airborne, (i.e., in face powders), and at quite high concentrations in cosmetic products that may be aerosolized, (e.g., 77% isopropyl myristate in hair sprays, 45% ethyl- hexyl palmitate in indoor tanning preparations, and 23% isopropyl myristate in deodorant formulations). There were no repeated- dose inhalation toxicity data available for the alkyl esters, but droplets/particles deposited in the nasopharyngeal or bronchial regions of the respiratory tract present no toxicological concerns based on the chemical and biological properties of these ingredi- ents. Coupled with the small actual exposure in the breathing zone and the concentrations at which the ingredients are used, the available information indicates that incidental inhalation would not be a significant route of exposure that might lead to local res- piratory or systemic effects. Also, these ingredients are large molecules and most are quite insoluble in water, which supports the view that they are unlikely to be absorbed or cause local effects in the respiratory tract. The Panel also considered the data avail- able to characterize the potential for alkyl esters to cause systemic toxicity, irritation, sensitization, or other effects, and noted that ingredients of this family tended not to produce systemic toxicity at high doses in single-dose oral, dermal, or inhalation studies, not to produce significant systemic toxicity in oral repeated-dose studies, not to be reproductive or developmental toxicants, and not to be genotoxic in a variety of systems. A detailed discussion and summary of the Panel’s approach to evaluating incidental inhalation exposures to ingredients in cosmetic products that may be aerosolized is available at http://www.cir-safety.org/cir- findings. CONCLUSION The CIR Expert Panel concluded that the 239 alkyl esters, listed below, are safe in the present practices of use and concentration described in this safety assessment when formulated to be non-irritating.

Arachidyl Behenate Cetyl Behenate* Heptylundecyl Hydroxystearate Arachidyl Erucate* Cetyl Caprate Hexyl Isostearate Arachidyl Propionate Cetyl Caprylate Hexyl Laurate Batyl Isostearate* Cetyl Dimethyloctanoate* Hexyldecyl Hexyldecanoate* Batyl Stearate* Cetyl Esters Hexyldecyl Isostearate Behenyl Beeswax Cetyl Isononanoate* Hexyldecyl Laurate Behenyl Behenate Cetyl Laurate Hexyldecyl Oleate* Behenyl Erucate Cetyl Myristate Hexyldecyl Palmitate* Behenyl Isostearate* Cetyl Myristoleate* Hexyldecyl Stearate Behenyl Olivate Cetyl Oleate* Hexyldodecyl/Octyldecyl Hydroxystearate* Behenyl/Isostearyl Beeswax* Cetyl Palmitate Hydrogenated Castor Oil Behenyl Esters* Butyl Avocadate Cetyl Ricinoleate Hydrogenated Castor Oil Cetyl Esters * Butyl Babassuate* Cetyl Stearate Hydrogenated Castor Oil Stearyl Esters* Butyl Isostearate* Cetyl Tallowate Hydrogenated Ethylhexyl Olivate Butyl Myristate Chimyl Isostearate* Hydrogenated Ethylhexyl Sesamate* Butyl Oleate* Chimyl Stearate* Hydrogenated Isocetyl Olivate* Butyl Stearate Coco-Caprylate Hydrogenated Isopropyl Jojobate* Butyloctyl Beeswax* Coco-Caprylate/Caprate Hydroxycetyl Isostearate* Butyloctyl Behenate* Coco-Rapeseedate* Hydroxyoctacosanyl Hydroxystearate Butyloctyl Candelillate* Decyl Castorate* Isoamyl Laurate Butyloctyl Cetearate* Decyl Cocoate Isobutyl Myristate* Butyloctyl Oleate* Decyl Isostearate* Isobutyl Palmitate* Butyloctyl Palmitate* Decyl Jojobate* Isobutyl Perlargonate* C10-40 Isoalkyl Acid Octyldodecanol Esters* Decyl Laurate* Isobutyl Stearate* C14-30 Alkyl Beeswax* Decyl Myristate* Isobutyl Tallowate* C16-36 Alkyl Stearate* Decyl Oleate Isocetyl Behenate* C18-38 Alkyl Beeswax* Decyl Olivate Isocetyl Isodecanoate* C18-38 Alkyl C24-54 Acid Ester* Decyl Palmitate* Isocetyl Isostearate* C20-40 Alkyl Behenate* Decyltetradecyl Cetearate* Isocetyl Laurate* C20-40 Alkyl Stearate Erucyl Arachidate* Isocetyl Myristate C30-50 Alkyl Beeswax* Erucyl Erucate* Isocetyl Palmitate C30-50 Alkyl Stearate* Erucyl Oleate* Isocetyl Stearate C32-36 Isoalkyl Stearate* Ethylhexyl Adipate/Palmitate/Stearate* Isodecyl Cocoate C40-60 Alkyl Stearate* Ethylhexyl C10-40 Isoalkyl Acidate* Isodecyl Hydroxystearate* C4-5 Isoalkyl Cocoate* Ethylhexyl Cocoate Isodecyl Isononanoate Caprylyl Butyrate* Ethylhexyl Hydroxystearate Isodecyl Laurate Caprylyl Caprylate Ethylhexyl Isononanoate Isodecyl Myristate Caprylyl Eicosenoate Ethylhexyl Isopalmitate Isodecyl Neopentanoate Cetearyl Behenate Ethylhexyl Isostearate Isodecyl Oleate Cetearyl Candelillate Ethylhexyl Laurate Isodecyl Palmitate* Cetearyl Isononanoate Ethylhexyl Myristate Isodecyl Stearate* Cetearyl Nonanoate* Ethylhexyl Neopentanoate* Isohexyl Caprate Cetearyl Olivate Ethylhexyl Oleate* Isohexyl Laurate* Cetearyl Palmate* Ethylhexyl Olivate Isohexyl Neopentanoate* Cetearyl Palmitate* Ethylhexyl Palmitate Isohexyl Palmitate* Cetearyl Rice Branate* Ethylhexyl Pelargonate Isolauryl Behenate* Cetearyl Stearate Ethylhexyl Stearate Isononyl Isononanoate Cetyl Babassuate Heptyl Undecylenate Isooctyl Caprylate/Caprate* 8

Isooctyl Tallate* Isotridecyl Stearate Octyldodecyl Stearate Isopropyl Isostearate Lauryl Behenate* Oleyl Arachidate* Isopropyl Arachidate* Lauryl Cocoate* Oleyl Erucate Isopropyl Avocadate* Lauryl Isostearate* Oleyl Linoleate Isopropyl Babassuate* Lauryl Laurate Oleyl Myristate* Isopropyl Behenate* Lauryl Myristate* Oleyl Oleate Isopropyl Hydroxystearate Lauryl Oleate/ Oleyl Stearate* Isopropyl Isostearate Lauryl Palmitate Propylheptyl Caprylate Isopropyl Jojobate Lauryl Stearate/ Stearyl Beeswax Isopropyl Laurate* Lignoceryl Erucate* Stearyl Behenate* Isopropyl Linoleate Myristyl Isostearate* Stearyl Caprylate Isopropyl Myristate Myristyl Laurate Stearyl Erucate* Isopropyl Oleate* Myristyl Myristate Stearyl Heptanoate Isopropyl Palmitate Myristyl Neopentanoate Stearyl Linoleate* Isopropyl Ricinoleate Myristyl Stearate Stearyl Olivate Isopropyl Sorbate* Octyldecyl Oleate* Stearyl Palmitate Isopropyl Stearate Octyldodecyl Avocadoate* Stearyl Stearate Isopropyl Tallowate* Octyldodecyl Beeswax* Tetradecyleicosyl Stearate* Isostearyl Avocadate Octyldodecyl Behenate* Tetradecyloctadecyl Behenate* Isostearyl Behenate Octyldodecyl Cocoate* Tetradecyloctadecyl Hexyldecanoate* Isostearyl Erucate* Octyldodecyl Erucate Tetradecyloctadecyl Myristate* Isostearyl Hydroxystearate Octyldodecyl Hydroxystearate* Tetradecyloctadecyl Stearate Isostearyl Isononanoate Octyldodecyl Isostearate Tetradecylpropionates* Isostearyl Isostearate Octyldodecyl Meadowfoamate* Tridecyl Behenate* Isostearyl Laurate Octyldodecyl Myristate Tridecyl Cocoate* Isostearyl Linoleate Octyldodecyl Neodecanoate* Tridecyl Erucate* Isostearyl Myristate Octyldodecyl Neopentanoate Tridecyl Isononanoate Isostearyl Neopentanoate Octyldodecyl Octyldodecanoate Tridecyl Laurate* Isostearyl Palmitate Octyldodecyl Oleate* Tridecyl Myristate* Isotridecyl Isononanoate Octyldodecyl Olivate Tridecyl Neopentanoate Isotridecyl Laurate* Octyldodecyl Ricinoleate Tridecyl Stearate Isotridecyl Myristate* Octyldodecyl Safflowerate*

*Not in current use. Were ingredients in this group not in current use to be used in the future, the expectation is that they would be used in product categories and at concentrations comparable to others in this group.

9

FIGURES Figure 1. Figures ordered by chain length, chemical structure

Structures, straight chain alkyl ingredients by total length 1. Cetyl Esters

2. Caprylyl Butyrate

3. Caprylyl Caprylate

4. Hexyl Laurate

5. Butyl Myristate

6. Decyl Laurate

7. Butyl Stearate

8. Arachidyl Propionate

9. Stearyl Caprylate

10. Decyl Myristate

10

11. Lauryl Laurate

12. Cetyl Caprylate

13. Tridecyl Laurate

14. Cetyl Caprate

15. Decyl Palmitate

16. Lauryl Myristate

17. Myristyl Laurate

18. Tridecyl Myristate

19. Myristyl Myristate

20. Cetyl Laurate

21. Lauryl Palmitate

22. Lauryl Stearate

11

23. Cetyl Myristate

24. Tridecyl Stearate

25. Myristyl Stearate

26. Cetyl Palmitate

27. Stearyl Palmitate

28. Cetyl Stearate

29. Lauryl Behenate

30. Stearyl Heptanoate

31. Tridecyl Behenate

32. Stearyl Stearate

O

H3C O CH3

33. Cetyl Behenate

12

34. Stearyl Behenate

35. Arachidyl Behenate

36. Behenyl Behenate

Unsaturated Straight chain 37. Heptyl Undecylenate

38. Butyl Oleate

39. Caprylyl Eicosenoate

40. Decyl Oleate

41. Cetyl Myristoleate

42. Lauryl Oleate

43. Oleyl Myristate

44. Cetyl Oleate

45. Tridecyl Erucate

13

46. Oleyl Stearate

47. Stearyl Linoleate

48. Oleyl Oleate

49. Oleyl Linoleate

50. Oleyl Arachidate

51. Stearyl Erucate

52. Erucyl Oleate

53. Oleyl Erucate

54. Arachidyl Erucate

55. Behenyl Erucate

56. Erucyl Arachidate

57. Erucyl Erucate

14

58. Lignoceryl Erucate

Branched, by longest length 59. Isohexyl Neopentanoate (one example of an “iso”)

60. Isopropyl Sorbate

61. Ethylhexyl Neopentanoate

62. Isobutyl Pelargonate

63. Isodecyl Neopentanoate (one example of an “iso”)

64. Ethylhexyl Isononanoate (one example of an “iso”)

65. Isohexyl Caprate (one example of an “iso”)

66. Isopropyl Laurate

67. Tridecyl Neopentanoate

68. Octyldodecyl Neopentanoate

15

69. Isononyl Isononanoate (one example of an “iso”)

70. Ethylhexyl Pelargonate

71. Propylheptyl Caprylate

72. Isopropyl Myristate

73. Myristyl Neopentanoate

74. Isobutyl Myristate

75. Isohexyl Laurate (one example of an “iso”)

76. Isoamyl Laurate

77. Isodecyl Isononanoate (one example of an “iso”)

16

78. Isopropyl Palmitate

79. Ethylhexyl Laurate

80. Isostearyl Neopentanoate (one example of an “iso”)

81. Isotridecyl Isononanoate

82. Ethylhexyl Myristate

83. Octyldodecyl Neodecanoate

84. Isobutyl Palmitate

85. Isopropyl Linoleate

86. Isopropyl Oleate

87. Isopropyl Isostearate (one example of an “iso”)

88. Isopropyl Stearate

17

89. Hexyldecyl Hexyldecanoate

90. Isodecyl Laurate (one example of an “iso”)

91. Isohexyl Palmitate (one example of an “iso”)

92. Isobutyl Stearate

93. Tridecyl Isononanoate

94. Butyl Isostearate (one example of an “iso”)

95. Ethylhexyl Isopalmitate (one example of an “iso”)

96. Ethylhexyl Palmitate

97. Isopropyl Arachidate (one example of an “iso”)

98. Hexyldecyl Laurate

18

99. Isodecyl Myristate (one example of an “iso”)

100. Hexyl Isostearate (one example of an “iso”)

101. Ethylhexyl Isostearate (one example of an “iso”)

102. Cetyl Isononanoate

103. Isotridecyl Laurate (one example of an “iso”)

104. Ethylhexyl Stearate

105. Octyldodecyl Octyldodecanoate

106. Octyldodecyl Myristate

107. Butyloctyl Palmitate

19

108. Ethylhexyl Oleate

109. Cetyl Dimethyloctanoate

110. Isopropyl Behenate (one example of an “iso”)

111. Isocetyl Isodecanoate (one example of an “iso”)

112. Isostearyl Isononanoate (one example of an “iso”)

113. Isodecyl Palmitate (one example of an “iso”)

114. Isotridecyl Myristate (one example of an “iso”)

115. Butyloctyl Oleate

116. Hexyldecyl Palmitate

117. Isodecyl Stearate (one example of an “iso”)

118. Hexyldecyl Isostearate (one example of an “iso”)

20

119. Decyl Isostearate (one example of an “iso”)

120. Isodecyl Oleate (one example of an “iso”)

121. Isocetyl Laurate (one example of an “iso”)

122. Tetradecyloctadecyl Hexyldecanoate

123. Hexyldecyl Oleate

124. Hexyldecyl Stearate

125. Octyldecyl Oleate

126. Isocetyl Myristate (one example of an “iso”)

127. Octyldodecyl Isostearate (one example of an “iso”)

128. Isostearyl Laurate (one example of an “iso”)

21

129. Lauryl Isostearate (one example of an “iso”)

130. Isotridecyl Stearate (one example of an “iso”)

131. Butyloctyl Behenate

132. Octyldodecyl Stearate

133. Octyldodecyl Oleate

134. Isostearyl Myristate (one example of an “iso”)

135. Isocetyl Palmitate (one example of an “iso”)

136. Tetradecyloctadecyl Myristate

137. Isocetyl Isostearate (one example of an “iso”)

138. Myristyl Isostearate (one example of an “iso”)

139. Isostearyl Palmitate (one example of an “iso”)

22

140. Isocetyl Stearate (one example of an “iso”)

141. Isolauryl Behenate (one example of an “iso”)

142. Octyldodecyl Behenate

143. Isostearyl Isostearate (one example of an “iso”)

144. Octyldodecyl Erucate

145. Isostearyl Linoleate (one example of an “iso”)

146. Tetradecyleicosyl Stearate

147. Tetradecyloctadecyl Stearate

148. Isocetyl Behenate (one example of an “iso”)

149. Behenyl Isostearate (one example of an “iso”)

23

150. Isostearyl Behenate (one example of an “iso”)

151. Isostearyl Erucate (one example of an “iso”)

O H C CH 3 O 3 CH3

152. Tetradecyloctadecyl Behenate

Hydroxy-substituted, by longest length 153. Isopropyl Hydroxystearate (one example of an “iso”)

154. Isopropyl Ricinoleate

155. Ethylhexyl Hydroxystearate

156. Isodecyl Hydroxystearate (one example of an “iso”)

157. Heptylundecyl Hydroxystearate

158. Octyldodecyl Ricinoleate

159. Octyldodecyl Hydroxystearate

24

160. Cetyl Ricinoleate

161. Hydroxycetyl Isostearate (one example of an “iso”)

162. Isostearyl Hydroxystearate (one example of an “iso”)

163. Chimyl Isostearate (one example of an “iso”)

164. Chimyl Stearate

165. Batyl Isostearate (one example of an “iso”)

166. Batyl Stearate

167. Hydroxyoctacosanyl Hydroxystearate

Mixtures (alphabetical) 168. Behenyl Beeswax

169. Behenyl/Isostearyl Beeswax (one example of an “iso”)

25

170. Behenyl Olivate

171. Butyl Avocadate

172. Butyl Babassuate

173. Butyloctyl Beeswax

174. Butyloctyl Candelillate

175. Butyloctyl Cetearate

176. C14‐30 Alkyl Beeswax

177. C18‐38 Alkyl Beeswax

178. C30‐50 Alkyl Beeswax

179. C20‐40 Alkyl Behenate

26

180. C18‐38 Alkyl C24‐54 Acid Ester

181. C16‐36 Alkyl Stearate

182. C20‐40 Alkyl Stearate

183. C30‐50 Alkyl Stearate

184. C40‐60 Alkyl Stearate

185. Cetearyl Behenate

186. Cetearyl Candelillate

187. Cetearyl Isononanoate (one example of an “iso”)

188. Cetearyl Nonanoate

189. Cetearyl Olivate

27

190. Cetearyl Palmate

191. Cetearyl Palmitate

192. Cetearyl Rice Branate

193. Cetearyl Stearate

194. Cetyl Babassuate

195. Cetyl Tallowate

196. C10‐40 Isoalkyl Acid Octyldodecanol Esters

197. C4‐5 Isoalkyl Cocoate

198. C32‐36 Isoalkyl Stearate

28

199. Coco‐Caprylate

O R wherein R represents the fatty alcohols O CH3 residues from coconut

200. Coco‐Caprylate/Caprate

201. Coco‐Rapeseedate

202. Decyl Castorate

203. Decyl Cocoate

204. Decyl Jojobate

205. Decyl Olivate

206. Decyltetradecyl Cetearate

29

207. Ethylhexyl Adipate/Palmitate/Stearate

208. Ethylhexyl C10‐40 Isoalkyl Acidate

209. Ethylhexyl Cocoate

210. Ethylhexyl Olivate

211. Hexyldodecyl/Octyldecyl Hydroxystearate

212. Hydrogenated Castor Oil Behenyl Esters

213. Hydrogenated Castor Oil Cetyl Esters

214. Hydrogenated Castor Oil Stearyl Esters

30

215. Hydrogenated Ethylhexyl Olivate

216. Hydrogenated Ethylhexyl Sesamate

217. Hydrogenated Isocetyl Olivate (one example of an “iso”)

218. Hydrogenated Isopropyl Jojobate

219. Isobutyl Tallowate

220. Isodecyl Cocoate (one example of an “iso”)

221. Isooctyl Caprylate/Caprate (one example of an “iso”)

222. Isooctyl Tallate (one example of an “iso”)

223. Isopropyl Avocadate (one example of an “iso”)

O CH O 3 whereinR represents the fatty acids derived from Avocado Oil H3C O R

224. Isopropyl Babassuate (one example of an “iso”) 31

O CH O 3 whereinR represents the fatty acids derived from Babassu Oil H3C O R

225. Isopropyl Jojobate

226. Isopropyl Tallowate

227. Isostearyl Avocadate (one example of an “iso”)

228. Lauryl Cocoate

229. Octyldodecyl Avocadoate

230. Octyldodecyl Beeswax

231. Octyldodecyl Cocoate

232. Octyldodecyl Meadowfoamate

32

233. Octyldodecyl Olivate

234. Octyldodecyl Safflowerate

235. Stearyl Beeswax

236. Stearyl Olivate

237. Tetradecylpropionates Chiefly:

Generally:

238. Tridecyl Cocoate

33

TABLES

Table 1. Alkyl Esters Group (presented alphabetically) Arachidyl Behenate Decyl Oleate# Isopropyl Isostearate Arachidyl Erucate Decyl Olivate Isopropyl Arachidate Arachidyl Propionate# Decyl Palmitate Isopropyl Avocadate Batyl Isostearate Decyltetradecyl Cetearate Isopropyl Babassuate Batyl Stearate Erucyl Arachidate Isopropyl Behenate Behenyl Beeswax Erucyl Erucate Isopropyl Hydroxystearate Behenyl Behenate Erucyl Oleate Isopropyl Isostearate# Behenyl Erucate Ethylhexyl Adipate/Palmitate/Stearate Isopropyl Jojobate Behenyl Isostearate Ethylhexyl C10-40 Isoalkyl Acidate Isopropyl Laurate Behenyl Olivate Ethylhexyl Cocoate# Isopropyl Linoleate Behenyl/Isostearyl Beeswax Ethylhexyl Hydroxystearate Isopropyl Myristate# Butyl Avocadate Ethylhexyl Isononanoate# Isopropyl Oleate Butyl Babassuate Ethylhexyl Isopalmitate Isopropyl Palmitate# Butyl Isostearate Ethylhexyl Isostearate Isopropyl Ricinoleate# Butyl Myristate# Ethylhexyl Laurate Isopropyl Sorbate Butyl Oleate Ethylhexyl Myristate# Isopropyl Stearate# Butyl Stearate# Ethylhexyl Neopentanoate Isopropyl Tallowate Butyloctyl Beeswax Ethylhexyl Oleate Isostearyl Avocadate Butyloctyl Behenate Ethylhexyl Olivate Isostearyl Behenate Butyloctyl Candelillate Ethylhexyl Palmitate# Isostearyl Erucate Butyloctyl Cetearate Ethylhexyl Pelargonate# Isostearyl Hydroxystearate Butyloctyl Oleate Ethylhexyl Stearate# Isostearyl Isononanoate# Butyloctyl Palmitate Heptyl Undecylenate Isostearyl Isostearate C10-40 Isoalkyl Acid Octyldodecanol Esters Heptylundecyl Hydroxystearate Isostearyl Laurate C14-30 Alkyl Beeswax Hexyl Isostearate Isostearyl Linoleate C16-36 Alkyl Stearate Hexyl Laurate Isostearyl Myristate# C18-38 Alkyl Beeswax Hexyldecyl Hexyldecanoate Isostearyl Neopentanoate# C18-38 Alkyl C24-54 Acid Ester Hexyldecyl Isostearate Isostearyl Palmitate C20-40 Alkyl Behenate Hexyldecyl Laurate Isotridecyl Isononanoate# C20-40 Alkyl Stearate Hexyldecyl Oleate Isotridecyl Laurate C30-50 Alkyl Beeswax Hexyldecyl Palmitate Isotridecyl Myristate# C30-50 Alkyl Stearate Hexyldecyl Stearate Isotridecyl Stearate C32-36 Isoalkyl Stearate Hexyldodecyl/Octyldecyl Hydroxystearate Lauryl Behenate C40-60 Alkyl Stearate Hydrogenated Castor Oil Behenyl Esters Lauryl Cocoate# C4-5 Isoalkyl Cocoate Hydrogenated Castor Oil Cetyl Esters Lauryl Isostearate Caprylyl Butyrate Hydrogenated Castor Oil Stearyl Esters Lauryl Laurate Caprylyl Caprylate Hydrogenated Ethylhexyl Olivate Lauryl Myristate# Caprylyl Eicosenoate Hydrogenated Ethylhexyl Sesamate Lauryl Oleate Cetearyl Behenate Hydrogenated Isocetyl Olivate Lauryl Palmitate Cetearyl Candelillate Hydrogenated Isopropyl Jojobate Lauryl Stearate Cetearyl Isononanoate# Hydroxycetyl Isostearate Lignoceryl Erucate Cetearyl Nonanoate# Hydroxyoctacosanyl Hydroxystearate Myristyl Isostearate Cetearyl Olivate Isoamyl Laurate Myristyl Laurate Cetearyl Palmate Isobutyl Myristate# Myristyl Myristate# Cetearyl Palmitate Isobutyl Palmitate Myristyl Neopentanoate Cetearyl Rice Branate Isobutyl Perlargonate# Myristyl Stearate# Cetearyl Stearate Isobutyl Stearate# Octyldecyl Oleate Cetyl Babassuate Isobutyl Tallowate Octyldodecyl Avocadoate Cetyl Behenate Isocetyl Behenate Octyldodecyl Beeswax Cetyl Caprate Isocetyl Isodecanoate Octyldodecyl Behenate Cetyl Caprylate Isocetyl Isostearate Octyldodecyl Cocoate# Cetyl Dimethyloctanoate Isocetyl Laurate Octyldodecyl Erucate Cetyl Esters Isocetyl Myristate Octyldodecyl Hydroxystearate Cetyl Isononanoate# Isocetyl Palmitate Octyldodecyl Isostearate Cetyl Laurate Isocetyl Stearate# Octyldodecyl Meadowfoamate Cetyl Myristate# Isodecyl Cocoate# Octyldodecyl Myristate# Cetyl Myristoleate Isodecyl Hydroxystearate Octyldodecyl Neodecanoate Cetyl Oleate Isodecyl Isononanoate# Octyldodecyl Neopentanoate Cetyl Palmitate# Isodecyl Laurate Octyldodecyl Octyldodecanoate Cetyl Ricinoleate# Isodecyl Myristate# Octyldodecyl Oleate Cetyl Stearate# Isodecyl Neopentanoate Octyldodecyl Olivate Cetyl Tallowate Isodecyl Oleate# Octyldodecyl Ricinoleate# Chimyl Isostearate Isodecyl Palmitate Octyldodecyl Safflowerate Chimyl Stearate Isodecyl Stearate Octyldodecyl Stearate Coco-Caprylate Isohexyl Caprate Oleyl Arachidate Coco-Caprylate/Caprate Isohexyl Laurate Oleyl Erucate Coco-Rapeseedate Isohexyl Neopentanoate Oleyl Linoleate Decyl Castorate Isohexyl Palmitate Oleyl Myristate# Decyl Cocoate# Isolauryl Behenate Oleyl Oleate Decyl Isostearate Isononyl Isononanoate# Oleyl Stearate Decyl Jojobate Isooctyl Caprylate/Caprate Propylheptyl Caprylate Decyl Laurate Isooctyl Tallate Stearyl Beeswax

34

Table 1. Alkyl Esters Group (presented alphabetically) Decyl Myristate# Stearyl Stearate# Tridecyl Cocoate# Stearyl Behenate# Tetradecyleicosyl Stearate Tridecyl Erucate Stearyl Caprylate# Tetradecyloctadecyl Behenate Tridecyl Isononanoate# Stearyl Erucate Tetradecyloctadecyl Hexyldecanoate Tridecyl Laurate Stearyl Heptanoate# Tetradecyloctadecyl Myristate# Tridecyl Myristate# Stearyl Linoleate Tetradecyloctadecyl Stearate Tridecyl Neopentanoate Stearyl Olivate# Tetradecylpropionates Tridecyl Stearate Stearyl Palmitate# Tridecyl Behenate #indicates the ingredient was reviewed previously by the CIR

Table 2. Conclusions (year issued) and data summaries of previously reviewed alkyl esters Alkyl Ester Conclusion (Year) Summary data Reference Final report on the safety assessment of arachidyl propionate. 7,13 Arachidyl Propionate safe as used (1990; - the acute oral LD50 in rats was >20 g/kg; up to 2500 mg/kg at concentrations of 25% in corn oil was reaffirmed 2008) not toxic in a 90-day oral study - the acute dermal LD50 in rabbits was > 2 g/kg - not a primary irritant to rabbit skin when tested undiluted, a formulation containing 7% was not irritating in a 24 h SIOPT, and a 10% solution was non-irritating and undiluted test article was slightly irritating in a cumulative irritation test; not a sensitizer when injected undiluted test material, and was not comedogenic when tested undiluted - undiluted test material and a formulation containing 7% were not irritating to rabbit eyes Final report on the amended safety assessment of and its salts and esters as used in cosmetics. (2010) Final report on the safety assessment of butyl myristate. (1990) - Discussion item: data on myristic acid myristyl and isopropyl myristate were extrapolated and also 16 used in the determination of safety (1990 report) Butyl Myristate safe as used (1990; - was observed to enhance dermal penetration of some chemicals 14,16 2010) - the oral LD50 in rats was >8 g/kg - a single application of 2 g/kg was non-toxic and non-irritating in rabbits - a 24 h occlusive application of undiluted test material produced moderate irritation (PII = 2.88) in rabbits; a moderate irritant but not a sensitizer in guinea pigs when injected intradermally - non-irritating to rabbit eyes Cetyl Myristate safe as used (2010) - no data were available 16 Decyl Myristate safe as used (2010) - no data were available 16 Ethylhexyl Myristate safe as used (2010) - no data were available 16 Isobutyl Myristate safe as used (2010) - no data were available 16 Isocetyl Myristate safe as used (2010) - no data were available 16 Isodecyl Myristate safe as used (2010) no data were available 16 Isopropyl Myristate safe as used (1982; - in a study in which monkeys were exposed for 5 sec to an aerosol antiperspirant containing an un- 10,16 2010) specified concentration of [14C]isopropyl myristate, the distribution in the exhaled air and in several tissues indicated only 0.25% of the sprayed dose was absorbed and about 10% of this reached the lower respiratory tract - the acute oral LD50 was >16 ml/kg in rats and 49.7 ml/kg in mice - the acute dermal LD50 in rabbits was 5 g/kg; dermal application of 2 g/kg a formulation containing 16-20% in rabbits for 26 days (20 applications) did not produce signs of toxicity but did cause severe erythema and moderate edema and other dermal effects and microscopically marked to severe acan- thosis and hyperkeratosis and mixed inflammatory cell infiltration; application of 2 ml/kg of a formu- lation containing 43-47% in rabbits for 4 wks (21 applications) produced erythema, edema, drying, cracking, and fissuring, but microscopic effects were only seen at the application site - 1 h inhalation exposure to formulations containing 16-20% (33-41 mg/l) and 4.7% (9.7 mg/l) did not produce any deaths or evidence of systemic toxicity in rats; in 13-wk inhalation studies, a formulation containing 16-20% was not toxic to guinea pigs (daily mean concentration of 63.3-224 mg/m3 air for three 1-h exposures/day) but did produce coughing and wheezing in monkeys. Macrophage accum- ulations within the alveolar and bronchiolar walls were seen in the lungs in direct proportion to the dosage of the aerosol (5.3-37.0 mg/m3 in air) - a 50% solution in significantly accelerated the carcinogenic activity of 0.15% benzo[a]pyrene on the skin of mice; no tumors were produced in mice by application of a 1% solution for 18 wks; applications of 10-100% to the backs of Swiss mice 2x/wk did not result in test article- related carcinogenic lesions - in Draize tests, undiluted test material and 15-58% in formulations was at mostly minimally irritating in rabbits, however, application of undiluted test material for 3 days was moderately to severely irritating; produced comedogenic activity in rabbit ears - in human testing, undiluted test material was not irritating (15 subjects) and the highest PII with formulations containing 15-58% was 0.1 (9-50%) in primary irritation studies; in cumulative irritation studies, undiluted test material (25 subjects) and formulations containing 15-58% (9-13 subjects) were minimally irritating; no sensitization was seen in maximization studies (20% in pet. or -42.9% in formulation; 25 subjects) or RIPTs (15 and 52-58%; 99 and 320 subjects); a formulation containing 42.9% was not phototoxic (10 subjects) or a photoallergen (25 subjects) - undiluted material was minimally irritating to rabbit eyes and formulations containing 15-58% were non- to mildly irritating

35

Table 2. Conclusions (year issued) and data summaries of previously reviewed alkyl esters Alkyl Ester Conclusion (Year) Summary data Reference - not genotoxic in the Salmonella/microsome test Isostearyl Myristate safe as used (2010) - mixed results were seen regarding dermal penetration enhancement 16 - in a study in which monkeys were exposed for 5 sec to an aerosol antiperspirant containing test material, the distribution in the exhaled air and in several tissues indicated only 0.25% of the sprayed dose was absorbed and about 10% of this reached the lower respiratory tract - no other data were available Isotridecyl Myristate safe as used (2010) - no data were available 16 Lauryl Myristate safe as used (2010) - no data were available 16 10,16 Myristyl Myristate safe as used (1982; - the acute oral LD50 in rats was >14.4 g/kg 2010) - the acute dermal LD50 in rabbits was >2 g/kg - undiluted test material was at most mildly irritating in rabbits; produced comedogenic activity in rabbit ears - in human studies, 8% in formulation was not an irritant (20 subjects) or sensitizer (196 subjects) - undiluted material, 15-50% in corn oil, and formulations containing 15-58% were non- to minimally irritating in rabbit eyes Octyldodecyl Myristate safe as used (2010) - no data were available 16 Oleyl Myristate safe as used (2010) - no data were available 16 Tetradecyloctadecyl safe as used (2010) - no data were available 16 Myristate Tridecyl Myristate safe as used (2010) - no data were available 16 Final report on the safety assessment of butyl stearate, cetyl stearate, isobutyl stearate, isocetyl stearate, isopropyl stearate, myristyl stearate, and octyl stearate. 5,11 Butyl Stearate safe as used (1985, - the acute oral LD50 in rats was >32 g/kg; in a 2 yr feeding study in rats with up to 6000 mg/kg/day, reaffirmed 2005) no test article-related toxicity was observed - dietary administration of 6.25% for to male and female rats for 10 wks prior to mating did not affect fertility, litter size, or neonate survival, but growth was decreased pre- and post-weaning - undiluted test material was at most moderately irritating (in one study) to rabbit skin (PIIs ranged from 0-2.75); 0.1% in physiological saline was not a sensitizer in 2 guinea pigs when tested using intracutaneous injections; 50% in mineral oil weakly comedogenic in rabbits in a 2 wk study - in human testing, 24 and 48 h occlusive patch testing with 2% in formulation resulted in PIIs of 0.03 and 0.11, respectively (number of subjects not specified); 50% in mineral oil was at most a mild irritant and was not a sensitizer in an RIPT (111 subjects); 10% in formulation was not an irritant, sensitizer, (54 subjects) or photosensitizer (10 subjects) - undiluted test material was not irritating to rabbit eyes Cetyl Stearate safe as used (1985, - 50% in mineral oil was at most a mild irritant and was not a sensitizer in an RIPT (111 subjects), 5,11 reaffirmed 2005) although sensitization was reported in 1 subject 5,11 Ethylhexyl Stearate safe as used (1985, - the acute oral LD50 in rats was >8 ml/kg (originally Octyl Stearate) reaffirmed 2005) - undiluted test material was at most mildly irritating to rabbit skin (PIIs 0.0 and 1.42); in a 6-day cumulative skin irritation study, undiluted test material had a MMII of 0.67 and was poorly tolerated and a 10% aq. solution had a MMII of 0.33 was relatively well tolerated - in human testing, a formulation containing 7.6% was not an irritant or sensitizer (56 subjects), not phototoxic (10 subjects), and not a photosensitizer (27 subjects), although some slight reactions were reported in the photosensitization study - undiluted test material did not provoke any significant injury in rabbit eyes (max PII 4.67/100 at 1 h) Discussion item: the Panel noted that the reproductive toxicity of 2-ethyl-1-hexanol was addressed in a fetotoxicity study (performed on diethylhexyl adipate); it was suggested that the fetotoxicity report- ed for mice in that study was actually due to a zinc deficiency and that given the extent of 2-ethyl-1- hexanol absorption and the load that would be expected to enter the hepatic circulation, the potential for 2-ethyl-1-hexanol-induced reproductive toxicity was not thought to be an issue Isobutyl Stearate safe as used (1985, - undiluted test material was mildly irritating to rabbit skin (PIIs =0.62) in a 24 h occlusive study 5,11 reaffirmed 2005) - in human testing, a mild irritant and not a sensitizer when tested undiluted in an RIPT (149 subjects); 50% in mineral oil was not phototoxic or a photosensitizer (23 subjects) Isocetyl Stearate safe as used (1985, - no data were available 5,11 reaffirmed 2005) Isopropyl Stearate safe as used (1985, - maximum reported use concentration was up to 25% in a leave-on formulation 5,11 reaffirmed 2005) - the acute oral LD50 in rats was >8 ml/kg - undiluted test material was moderately irritating to rabbit skin (PIIs 2.35 in two studies) - in human testing, 1.0% in formulation was non- (105 subjects) to slightly irritating (12 subjects) and produced no adverse reactions in a 4-wk use test (40 subjects) - undiluted test material was not irritating to rabbit eyes Myristyl Stearate safe as used (1985, - maximum reported use concentration was up to 5% in a leave-on formulation 5,11 reaffirmed 2005) - the acute oral LD50 in mice was >10 g/kg with corn oil and >1 g/kg neat - undiluted test material was not irritating to rabbit skin (PII = 0.0) - in human testing, formulations containing 2.35 – 9.8% produced no skin reactions in open and closed patch tests 22-100 subjects/test) - undiluted test material produced slight vessel injection involving only the conjunctivae at 24 h and no irritation was observed on days 2-7

36

Table 2. Conclusions (year issued) and data summaries of previously reviewed alkyl esters Alkyl Ester Conclusion (Year) Summary data Reference Final report on the safety assessment of pelargonic acid (aka nonanoic acid) and the nonanoate esters) Discussion items: because of the skin penetration enhancement property of pelargonic acid in the 19 presence of p-aminobenzoic acid, care should be taken in formulating products containing this ingredient in combination with any ingredients whose safety was based on lack of dermal absorption or when dermal absorption was a concern; because animal sources have been reported, this ingredient must be free of detectable pathogenic viruses or infectious agents 19 Cetearyl Isononanoate safe as used (2010) - the oral LD50 in mice was >5 g/kg; in an oral study in which rats were dosed with 100, 300, or 1000 mg/kg, reversible fatty alterations were induced in the liver of female mid dose and male and female high dose animals and the NOAEL was 100 mg/kg/day - not a reproductive toxicant in a study in which 100-1000 mg/kg was administered orally to gravid rats on days 6-15 of gestation, and the NOAEL for maternal and embryo-/fetotoxicity was 100 mg/kg - not mutagenic in an Ames test at doses up to 5000 µg/plate with or without metabolic activation - slightly irritating to the skin of hairless mice and not irritating to rabbit skin; not a sensitizer in guinea pigs (25% injected intracutaneously at induction and challenge); 10-100% was not comedogenic in rabbit ears - in human testing, 20% active and undiluted test material had very good skin compatibility in a 24-h SIOPT (21 subjects); a formulation containing 1.5% was not a contact allergen in a maximization test (25 subjects) and undiluted test material was not an irritant or sensitizer in a provocative RIPT (20 eczema patients) - 10% active was not irritating to rabbit eyes 19 Cetearyl Nonanoate safe as used (2010) - the oral LD50 in rats was 2 g/kg - the acute dermal LD50 in rats was >2 g/kg and there was no dermal irritation observed - undiluted test material (97% pure) was non-irritating to rabbit skin; not a sensitizer in a GPMT (10% for intracutaneous induction, 50% for topical induction, 10% at challenge, sesame oil was the vehicle) - not mutagenic in an Ames test at doses up to 5000 µg/plate with or without metabolic activation - in human testing, undiluted test material (97% pure) was not an irritant in a 48-h SIOPT (52 subjects); undiluted test material was not an irritant or a sensitizer in a RIPT (106 subjects) - undiluted test material was minimally irritating to rabbit eyes Cetyl Isononanoate safe as used (2010) - no data were available 19 Ethylhexyl Isononanoate safe as used (2010) - not mutagenic in an Ames test at doses up to 5000 µg/plate with or without metabolic activation 19 - in human testing, undiluted test material did not indicate potential for allergic contact sensitization in an RIPT (10 subjects) 19 Ethylhexyl Pelargonate safe as used (2010) - the acute oral LD50 in rats was >5 g/kg - undiluted test material was not irritating to rabbit skin (PII = 0.40) - undiluted test material was not irritating to rabbit eyes Isobutyl Pelargonate safe as used (2010) - no data were available 19 Isodecyl Isononanoate safe as used (2010) - in human testing, a formulation containing 51.35% was not an irritant or sensitizer in a RIPT (101 19 subjects) and a formulation containing 2.6% was not a contact allergen in a maximization test (26 subjects) 19 Isononyl Isononanoate safe as used (2010) - the acute oral LD50 in rats was >5 g/kg; 300 and 1000 mg/kg/day induced mortality and all doses (100-1000mg/kg/day) induced liver and kidney toxicity in a 4-wk oral study in rats - 300 mg/kg/day (2 wks) and 860 mg/kg/day (8 days) induced liver and adrenal gland toxicity in a dermal study in rats - did not induce direct embryotoxicity or fetotoxicity in rats at doses up to 3000 mg/kg/day - not mutagenic in an Ames test at doses up to 5000 µg/plate with or without metabolic activation - slightly irritating to rabbit skin (study details not provided) - in human testing, lipstick formulations containing 3.552% (53 subjects) and 3.128% (97 subjects) were not irritants or sensitizers in RIPTs and a formulation containing 24.66% was not a contact allergen in a maximization test (26 subjects) - not irritating to rabbit eyes (concentration tested was not stated) Isostearyl Isononanoate safe as used (2010) -no data were available 19 Isotridecyl Isononanoate safe as used (2010) - in human testing, a formulation containing 4.3% was not a contact allergen in a maximization test 19 (28 subjects) Tridecyl Isononanoate safe as used (2010) - no data were available 19 Final report on the safety assessment of cetyl esters Cetyl Esters safe as used (1997) - (synonymous with synthetic spermaceti wax) a commercial cetyl esters preparation comprised of a 1 mixture of one or more of the following esters: cetyl palmitate, myristyl myristate, cetyl stearate, myristyl stearate, cetyl myristate, and stearyl stearate - the oral LD50 in mice of a formulation containing 60-65% >20 g/kg - a formulation containing 60-65% was not irritating to rabbit skin in a 24 h SIOPT - a formulation containing 60-65% was not an irritant to rabbit eyes Discussion item: data from the safety assessments on cetyl palmitate, myristyl myristate, cetyl stearate, and myristyl stearate were extrapolated to determine safety Final report on the safety assessment of octyl palmitate, cetyl palmitate, and isopropyl palmitate Cetyl Palmitate safe as used (1982; - was quantitatively excreted in the feces of male rats when fed at 20% in the diet 5,9 reaffirmed in 2005) - acute oral LD50 was > 14.4 g/kg in rats; not toxic in a 9-day dietary study in rats - no mortality was observed when a 50% slurry was applied to rabbit skin under an occlusive patch - was at most mildly irritating in rabbits when applied undiluted or in formulation (2.5-2.7%) under occlusion; a 1% suspension produced minimal irritation and was not sensitizing in the Landsteiner and 37

Table 2. Conclusions (year issued) and data summaries of previously reviewed alkyl esters Alkyl Ester Conclusion (Year) Summary data Reference Jacobs test in guinea pigs - in humans, a formulation containing 2.7% was not a primary irritant (10 subjects); in maximization studies, a formulation containing 2.5% was classified as a weak potential sensitizer that was unlikely to present a risk of contact sensitization under conditions of normal use (50 subjects) and one contain- ing 2.7% was classified as a weak potential sensitizer of the lowest grade (25 subjects); a formulation containing 2.7% was not phototoxic (10 subjects) or photoallergenic (25 subjects); low irritation potential was observed in in-use studies (28-56 days; 30-100 subjects per study) - minimally irritating to rabbit eyes; OIIs ranged from 0.3 – 6.7 for undiluted test material and 0.0 for a 5% (w/w) dispersion 5,9 Ethylhexyl Palmitate safe as used (1982; - the acute oral LD50 was >64 ml/kg in rats (originally, Octyl Palmitate) reaffirmed in 2005) - the acute dermal LD50 was >9.4 ml/kg in rabbits (only 2 rabbits in each group); dermal toxicity was not observed in a 6 wk dermal study with undiluted material; undiluted test material was “poorly tolerated” in a 60-day study with “congestive dermatitis” in 2/3 rabbits - was a mild irritant tested undiluted in an SIOPT in rabbits; 0.1% suspensions were not sensitizers in the Landsteiner and Jacobs test in guinea pigs - in human studies, 3 formulations containing 1-5% and one containing 40-50% tested in 48-h occlusive tests with 100 subjects and 3 formulations containing 45.72-46.52% tested in an 18 day occlusive RIPT with 20 subjects were not irritants, and in a 21-day occlusive RIPT a formulations containing 42.25% resulted in signs of irritation in 7/24 subjects and the avg. cumulative irritation score was 2.58/84 - OIIs for undiluted test material ranged from 0.33 – 4.17 in 3 Draize studies, indicating that it did not cause significant injury to rabbit eyes 5,9 Isopropyl Palmitate safe as used (1982; - the acute oral LD50 was >64 ml/kg in rats reaffirmed in 2005) - the dermal LD50 was >2.0 ml/kg in rabbits - no inhalation toxicity in rats exposed to 200mmg/l for 1 h - undiluted test material was non-irritating to slightly irritating to rabbit skin - in human testing, in 3 studies with 24-h occlusive patches with undiluted test material performed in a total of 160 subjects, there were five irritation scores of 0.5/4, and the remainder were 0/4 and in a 10- day primary irritation study, a formulation containing 45.6% was not irritating in 10 subjects; not a sensitizer when tested undiluted in an RIPT with 102 subjects or in formulation at 45.6% in a maximization test with 25 subjects; a formulation containing 45.6% was not phototoxic (10 subjects) or photoallergenic (25 subjects) - OIIs ranged from 0.0 – 6.5 in 5 Draize studies, indicating that it did not cause significant injury to rabbit eyes Final report on the safety assessment of Ricinus communis (castor) seed oil, hydrogenated castor oil, glyceryl ricinoleate, glyceryl ricinoleate se, ricinoleic acid, potassium ricinoleate, sodium ricinoleate, zinc ricinoleate, cetyl ricinoleate, ethyl ricinoleate, glycol ricinoleate, isopropyl ricinoleate, methyl ricinoleate, and octyldodecyl ricinoleate - Discussion item: safety test data on Ricinus Communis (Castor) Seed Oil, which contains ricinoleic acid (and for which data were included), was considered applicable for extrapolation to determine safety; retrospective study reports of sensitization reactions to ricinoleic acid in patients with eczema- tous cheilitis was determined to be expected in that patient group but not the general population, and based on the Panel’s expertise and experience, the incidence of positive reactions to ricinoleic acid were very low 20 Cetyl Ricinoleate safe as used (2007) - the acute oral LD50 in mice was >2 g/kg - not irritating to rabbit skin (test concentration not stated) Isopropyl Ricinoleate safe as used (2007) - no specific safety data were available 20 Octyldodecyl Ricinoleate safe as used (2007) - no specific safety data were available 20 Final report on the safety assessment of Cocos nucifera (coconut) oil and related ingredients Discussion items: because there is no reason to expect the toxicity to differ from that of coconut oil, coconut acid, hydrogenated coconut oil, and hydrogenated coconut acid and therefore the data avail- able on these ingredients are supportive of safety; necessary procedures should be continued by the cosmetics industry to limit pesticide residues and heavy metals Decyl Cocoate safe as used (2011) - no data were available 17 Ethylhexyl Cocoate safe as used (2011) - no data were available 17 Isodecyl Cocoate safe as used (2011) - no data were available 17 Lauryl Cocoate safe as used (2011) - no data were available 17 Octyldodecyl Cocoate safe as used (2011) - no data were available 17 Tridecyl Cocoate safe as used (2011) - no data were available 17 Final report on the safety assessment of decyl and isodecyl oleates 4,36 Decyl Oleate safe as used (1982; - the acute oral LD50 was > 40 ml/kg and >5 g/kg in rats reaffirmed in 2003) - in a primary dermal irritation study using rabbits, the PIIs for a 10% solution in corn oil, and 20% solution in mineral oil, and undiluted test material were 0.08, 0.05, and 0.28, respectively, and in a modified Draize test, a 15% solution in polyoxyethylene sorbitan stearate (3%), preservative (2%), and water and undiluted test material were non-irritating; in an 8-wk study in rabbits, daily application of the 15% solution produced some papulae or vesicles but was generally well tolerated and the un- diluted material resulted in skin thickening in 3 rabbits (total tested not stated) and vesicles in 1 rabbit and was poorly tolerated; a 15% solution in corn oil was not a sensitizer in the Landsteiner and Jacobs test in guinea pigs - in human testing, no sensitization was reported in a RIPT in 103-subject with a formulation 38

Table 2. Conclusions (year issued) and data summaries of previously reviewed alkyl esters Alkyl Ester Conclusion (Year) Summary data Reference containing 1-5% or in 402 subjects with 4 formulations containing 5.5% - at most, a very slight irritant to rabbit eyes when tested undiluted 4,36 Isodecyl Oleate safe as used (1982; - the acute LD50 was > 40 ml/kg in rats reaffirmed in 2003) - undiluted test material had a PII of 1.0 in 3 rabbits, but subsequent testing reported a PII of 0.28 and additional studies with undiluted the a 15% solution in polyoxyethylene sorbitan stearate (3%), preservative (2%), and water indicated reported the material was non-irritating (PII scores of 0.0 and 0.13 for the undiluted material and 0.0 for the 15% solution); in an 8-wk study in rabbits, daily application of the 15% solution produced episodical macules, papulae, and vesicles but was relatively well tolerated and the undiluted material was poorly tolerated with congestive dermis effects; a 15% solution in corn oil was not a sensitizer in the Landsteiner and Jacobs test in guinea pigs - in humans, undiluted test material was not an irritant in an SIOPT in 19 subjects and in a 21-day cumulative irritancy test in 9 subjects with undiluted material, the irritation score was 1.0/756 - at most, a very slight irritant to rabbit eyes when tested undiluted Final report on the safety assessment of isopropyl isostearate Isopropyl Isostearate safe as used (1992, - undiluted test material was a non-irritant (PII = 0.42) in rabbit skin 24 and 72 h after application, and 2,8 reaffirmed in 2011) in an 8-wk study a 10% aq. solution was relatively well tolerated (IIMM = 2.00) but the undiluted material was poorly tolerated (IIMM = 3.34) and discontinued after 5 wks; undiluted test material induced severe comedones in rabbit ears - 10% aq. and undiluted test material were slight ocular irritants in rabbit eyes Discussion item: because limited toxicological data (dermal irritation, ocular irritation, and comedo- genicity data) were available, the Panel used data on similar isopropyl esters that had already been reviewed and found safe to determine safety Final report on the safety assessment of isopropyl linoleate 15 Isopropyl Linoleate insufficient to - the oral LD50 in rats of 10% in corn oil was >64 cc/kg support safety - 10% aq. and undiluted test material were classified as slightly irritant and non-irritant, respectively, (1992) in primary irritation studies in rabbits; both 10% aq. and undiluted test materials were slight irritants when the study was repeated with purer samples; in another primary skin irritation study, 10% in corn oil did not product any irritation reactions in albino rabbits - 10% aq. and undiluted test material were slight ocular irritants, while 10% in corn oil was not irritating to rabbit eyes Discussion item: human irritation and sensitization data and genotoxicity data were needed Final report on the safety assessment of isostearyl neopentanoate 6,12 Isostearyl Neopentanoate safe as used (1985, - the acute oral LD50 was >40 ml/kg in rats; in a 93 day study, oral administration of undiluted test reaffirmed in 2006) material in rats was safe in terms of cumulative systemic toxicity - undiluted test material applied under a 24 h patch was not irritating to rabbit skin and formulations containing 1.2 – 32% was a most mildly irritating in rabbits; not considered a sensitizer in a GPMT (observations were attributed to scratches) and not a sensitizer in the Landsteiner and Jacobs test in guinea pigs; a formulation containing 3% was a mild primary skin irritant but was not phototoxic; 50% in mineral oil was marginally comedogenic and undiluted was non-comedogenic in rabbit ears - in human testing, was non-irritating in a 48-h SIOPT when tested undiluted or in formulations con- taining 3-5% (10 or 100 subjects), 4% in formulation (20 subjects) was minimally irritating (PII = 0.08) and 1.2% in formulation was non-irritating (20 subjects) in a 24-h SIOPT, a formulation con- taining 3% was mildly irritating in a 21-day study (15 subjects); undiluted test material and formula- tions containing 5-32% were not sensitizers in RIPT studies (52-210 subjects per study), although some irritation was reported; a formulation containing 16.05% was not phototoxic or a photoallergen in 27 subjects - undiluted test material was minimally irritating in rabbit eyes and formulations containing 1.2 – 36% were at most minimally irritating Discussion items: because of the skin penetration enhancement property of pelargonic acid in the presence of p-aminobenzoic acid, care should be taken in formulating products containing this ingredient in combination with any ingredients whose safety was based on lack of dermal absorption or when dermal absorption was a concern Final report on stearyl heptanoate and related stearyl alkanoates as used in cosmetics Final report on the safety assessment of stearyl heptanoate Discussion items: data from the original review on stearyl heptanoate were applicable to determine 18 safety, including extrapolated data on stearyl alcohol and heptanoic acid Stearyl Behenate safe as used (2010) - no data were available 18 Stearyl Caprylate safe as used (2010) - no data were available 18 3,18 Stearyl Heptanoate safe as used (1995, - the oral LD50 in rats was >16 ml/kg reaffirmed 2010) - a mixture that also contained stearyl caprylate was not mutagenic in an Ames test with or without metabolic activation and had no clastogenic effect in an in vivo micronucleus test in which mice were given a single oral dose of 500-1500 mg/kg in corn oil - undiluted test material was mildly irritating to rabbit skin (PII = 1.21/8); a formulation containing 1.5% was not a sensitizer in guinea pigs; a formulation containing 1.5% produced slight to moderate comedogenicity in rabbit ears - in human testing, cosmetic formulations containing 0.7% (198 subjects) and 1.5% (156, 194, and 202 subjects) were not sensitizers in RIPTs - undiluted test material was a Category 3 ocular irritant in rabbit eyes and a formulation containing 1.5% was not a primary ocular irritant Discussion items: although irritation testing was performed at 100%, sensitization testing was only

39

Table 2. Conclusions (year issued) and data summaries of previously reviewed alkyl esters Alkyl Ester Conclusion (Year) Summary data Reference performed with a maximum concentration of 1.5%; however, there was no indication that this ingredient would be a sensitizer; mild reactions were observed in ocular irritation studies with undiluted material and no irritation with a formulation containing 1.5%, therefore the Panel was of the opinion that in formulation, this ingredient would not produce significant ocular irritation; because there was limited information available, data on stearyl alcohol and heptanoic acid were extrapolated to determine safety Stearyl Olivate safe as used (2010) - no data were available 18 Stearyl Palmitate safe as used (2010) - no data were available 18 Stearyl Stearate safe as used (2010) - no data were available 18 Abbreviations: GPMT = guinea pig maximization test; IIMM = maximum irritation index; OII =ocular irritation index; PII = primary irritation index; RIPT = repeated insult patch test; SIOPT = single insult occlusive patch test

Table 3. Alkyl Esters Group (grouped by whether individual constituents have been reviewed) INGREDIENTS HAVE BEEN REVIEWED BY THE CIR AND FOUND SAFE* Arachidyl Propionate Ethylhexyl Stearate Isotridecyl Myristate Butyl Myristate Isobutyl Myristate Lauryl Cocoate Butyl Stearate Isobutyl Perlargonate Lauryl Myristate Cetearyl Isononanoate Isobutyl Stearate Myristyl Myristate Cetearyl Nonanoate Isocetyl Myristate Myristyl Stearate Cetyl Esters Isocetyl Stearate Octyldodecyl Cocoate Cetyl Isononanoate Isodecyl Cocoate Octyldodecyl Myristate Cetyl Myristate Isodecyl Isononanoate Octyldodecyl Ricinoleate Cetyl Palmitate Isodecyl Myristate Oleyl Myristate Cetyl Ricinoleate Isodecyl Oleate Stearyl Behenate Cetyl Stearate Isononyl Isononanoate Stearyl Caprylate Decyl Cocoate Isopropyl Isostearate Stearyl Heptanoate Decyl Myristate Isopropyl Myristate Stearyl Olivate Decyl Oleate Isopropyl Palmitate Stearyl Palmitate Ethylhexyl Cocoate Isopropyl Ricinoleate Stearyl Stearate Ethylhexyl Isononanoate Isopropyl Stearate Tetradecyloctadecyl Myristate Ethylhexyl Myristate Isostearyl Isononanoate Tridecyl Cocoate Ethylhexyl Palmitate Isostearyl Myristate Tridecyl Isononanoate Ethylhexyl Pelargonate Isostearyl Neopentanoate Tridecyl Myristate Isotridecyl Isononanoate BOTH THE ACID AND THE ALCOHOL HAVE BEEN FOUND SAFE BY THE CIR Batyl Isostearate Cetyl Oleate Isostearyl Isostearate Batyl Stearate Chimyl Isostearate Isostearyl Laurate Behenyl Isostearate Chimyl Stearate Isostearyl Palmitate Behenyl Olivate Hydrogenated Castor Oil Behenyl Esters Myristyl Isostearate Butyl Isostearate Hydrogenated Castor Oil Cetyl Esters Myristyl Laurate Butyl Oleate Hydrogenated Castor Oil Stearyl Esters Octyldodecyl Hydroxystearate Cetearyl Olivate Isopropyl Hydroxystearate Octyldodecyl Isostearate Cetearyl Palmate Isopropyl Laurate Octyldodecyl Oleate Cetearyl Palmitate Isopropyl Oleate Octyldodecyl Olivate Cetearyl Rice Branate Isopropyl Sorbate Octyldodecyl Stearate Cetearyl Stearate Isostearyl Hydroxystearate Oleyl Oleate Cetyl Laurate Oleyl Stearate THE ACID OR THE ALCOHOL HAS BEEN FOUND SAFE BY THE CIR Behenyl Beeswax Ethylhexyl Laurate Isopropyl Jojobate Behenyl Behenate Ethylhexyl Oleate Isopropyl Tallowate Behenyl Erucate Erucyl Oleate Isostearyl Avocadate Isostearyl Behenate Behenyl/Isostearyl Beeswax Heptylundecyl Hydroxystearate Isostearyl Erucate Butyl Avocadate Hexyldecyl Isostearate Isostearyl Linoleate Butyl Babassuate Hexyldecyl Laurate Isotridecyl Laurate Butyloctyl Cetearate** Hexyldecyl Oleate Isotridecyl Stearate Butyloctyl Oleate Hexyldecyl Palmitate Lauryl Isostearate Butyloctyl Palmitate Hexyldecyl Stearate Lauryl Laurate C16-36 Alkyl Stearate Hexyldodecyl/Octyldecyl Hydroxystearate Lauryl Oleate C20-40 Alkyl Stearate Hexyl Isostearate Lauryl Palmitate C30-50 Alkyl Stearate Hexyl Laurate Lauryl Stearate C40-60 Alkyl Stearate Hydrogenated Ethylhexyl Olivate Myristyl Neopentanoate Cetearyl Behenate Hydrogenated Ethylhexyl Sesamate Octyldecyl Oleate Cetearyl Candelillate Hydrogenated Isocetyl Olivate Octyldodecyl Avocadoate Cetyl Babassuate Hydrogenated Isopropyl Jojobate Octyldodecyl Beeswax Cetyl Behenate Hydroxycetyl Isostearate Octyldodecyl Behenate Cetyl Caprate Hydroxyoctacosanyl Hydroxystearate Octyldodecyl Erucate Cetyl Caprylate Isoamyl Laurate Octyldodecyl Meadowfoamate Cetyl Dimethyloctanoate Isobutyl Palmitate Octyldodecyl Neodecanoate Cetyl Tallowate Isocetyl Isostearate Octyldodecyl Neopentanoate C10-40 Isoalkyl Acid Octyldodecanol Esters Isocetyl Laurate Octyldodecyl Octyldodecanoate

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Table 3. Alkyl Esters Group (grouped by whether individual constituents have been reviewed) C4-5 Isoalkyl Cocoate Isocetyl Palmitate Octyldodecyl Safflowerate C32-36 Isoalkyl Stearate Isodecyl Hydroxystearate Oleyl Arachidate Coco-Caprylate Isodecyl Laurate Oleyl Erucate Coco-Caprylate/Caprate Isodecyl Palmitate Oleyl Linoleate Coco-Rapeseedate Isodecyl Stearate Stearyl Beeswax Decyl Isostearate Isohexyl Laurate Stearyl Erucate Decyl Laurate Isohexyl Palmitate Stearyl Linoleate Decyl Palmitate Isooctyl Tallate Tetradecyleicosyl Stearate Decyltetradecyl Cetearate Isopropyl Arachidate Tetradecyloctadecyl Stearate Ethylhexyl Adipate/Palmitate/Stearate Isopropyl Avocadate Tridecyl Laurate Ethylhexyl Hydroxystearate Isopropyl Babassuate Tridecyl Stearate Ethylhexyl Isostearate Isopropyl Behenate CIR HAS NOT CONCLUDED ON THE SAFETY OF THE ACID OR THE ALCOHOL Arachidyl Behenate Decyl Jojobate Isodecyl Neopentanoate Arachidyl Erucate Ethylhexyl C10-40 Isoalkyl Acidate Isohexyl Caprylate Butyloctyl Beeswax Ethylhexyl Isopalmitate Isohexyl Neopentanoate Butyloctyl Behenate Ethylhexyl Neopentanoate Isolauryl Behenate Butyloctyl Candelillate Ethylhexyl Olivate Isooctyl Caprylate/Caprate C14-30 Alkyl Beeswax Erucyl Arachidate Lauryl Behenate C18-38 Alkyl Beeswax Erucyl Erucate Lignoceryl Erucate C30-50 Alkyl Beeswax Heptyldecyl Undecylenate Propylheptyl Caprylate C20-40 Alkyl Behenate Hexyldecyl Hexyldecanoate Tetradecyloctadecyl Behenate C18-38 Alkyl C24-54 Acid Ester Isobutyl Tallowate Tetradecyloctadecyl Hexyldecanoate Caprylyl Butyrate Isocetyl Behenate Tetradecylpropionates Caprylyl Caprylate Isocetyl Isodecanoate Tridecyl Behenate Caprylyl Eicosenoate Tridecyl Erucate Decyl Castorate Tridecyl Neopentanoate *Isopropyl Linoleate was reviewed previously by the CIR, with a conclusion of insufficient data to support safety **the acid component is a mixture of fatty acids, containing predominantly palmitic and stearic acids, both of which have been reviewed

Table 4. Constituent alcohols and acids with CIR conclusions Constituent Conclusion (year issued; maximum use concentration reported) Reference ALCOHOLS Batyl Alcohol safe as used (2011; 3% in leave-ons, 1% in rinse-offs) 25 Behenyl Alcohol safe as used (1988; reaffirmed 2008; 50% in leave-ons; 10% in rinse-offs) 7,31 Butyl Alcohol safe as used (2008; 15% in leave-ons; ≤0.1% in rinse-offs) 67 Cetearyl Alcohol safe as used (1988; reaffirmed 2008; 25% in leave-ons; 25% in rinse-off) 7,31 Cetyl Alcohol safe as used (1988; reaffirmed 2008; 50% in leave-ons; 25% in rinse-offs) 7,31 Cetyl Glycol (Hydroxycetyl Alcohol) safe as used (2011; no reported use) 26 Chimyl Alcohol safe as used (2011; 0.5% in leave-ons, 0.002% in rinse-offs) 25 Coconut Alcohol safe as used (2011; 0.9% in leave-ons; 0.8% in rinse-offs) 17 Isopropyl Alcohol safe as used (2012; 100% in leave-ons; 35% in rinse-offs) 23 Isostearyl Alcohol safe as used (1988; reaffirmed 2008; 50% in leave-ons; 5% in rinse-offs) 7,31 Jojoba Alcohol safe as used (2008; 1% in leave-ons; 0.5% in rinse-offs) 28 Myristyl Alcohol safe as used (1988; reaffirmed 2008; 12% in leave-ons; 7% in rinse-offs) 7,31 Octyldodecanol safe as used (1985, reaffirmed 2006; 85% in leave-ons; 30% in rinse-offs) 6,33 Oleyl Alcohol safe as used (1985; reaffirmed 2006; >50% in leave-ons; 25% in rinse-offs) 6,33 Stearyl Alcohol safe as used (1985; reaffirmed 2006; 56% in leave-ons; 25% in rinse-offs) 6,33 ACIDS Adipic Acid safe as used (2012; 0.000001% in leave-on; 18% in rinse-off) 22 Babassu Acid safe as used (2011; no reported use) 24 Coconut Acid safe as used (2011; not reported in leave-ons; 14% in rinse-offs) 17,24 Hydroxystearic Acid safe as used (1999; 10% in leave-ons; not reported for rinse-offs) 29 Isostearic Acid safe as used (1983; reaffirmed in 2005; 16% in leave-ons, 26% in rinse-offs) 5,34 Lauric Acid safe as used (1987; reaffirmed in 2006; 10% in leave-ons, 25% in rinse-offs) 6,32 Myristic Acid safe as used (2010; 15% in leave-ons; 50% in rinse-offs) 16 Oleic Acid safe as used (1987; reaffirmed in 2006; 25% in leave-ons; 50% in rinse-offs) 6,32 Olive Acid safe as used (2011; no reported use) 24 Palm Acid safe as used (2011; not reported in leave-ons; 17% in rinse-offs) 24 safe as used (1987; reaffirmed in 2006; 25% in leave-ons, 25% in rinse-offs) 6,32 Pelargonic Acid safe as used (2011; no reported use) 19 Rice Bran Acid safe as used (2011; no reported use) 24 Ricinoleic Acid safe as used (2007; use concentration not reported) 20 Safflower Acid safe as used (2011; no reported use) 24 Sorbic Acid safe as used (1988; reaffirmed in 2008; 5% in leave-ons; 5% in rinse-offs) 7,30 Stearic Acid safe as used (1987; reaffirmed in 2006; >50% in leave-ons; 50% in rinse-offs) 6,32 Tall Oil Acid safe as used (2009; not reported in leave-ons; 8% in rinse-offs) 27

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Table 5. Definitions and functions Ingredient/CAS No. Definition37 (italicized text generated by CIR) Function37 Arachidyl Behenate the ester of arachidyl alcohol and behenic acid. The ester obtained from the reaction skin cond. agent – oc.; visc. incr. 42233-14-7 of arachidyl alcohol with behenic acid. agent – nonaq. Arachidyl Erucate the ester of arachidyl alcohol and erucic acid. The ester obtained from the reaction of skin cond. agent – emol. 86601-86-7 arachidyl alcohol with erucic acid. Arachidyl Propionate the ester of arachidyl alcohol and n-propionic acid. The ester obtained from the skin cond. agent – emol. 65591-14-2 reaction of arachidyl alcohol and n-propionic acid. Batyl Isostearate an ester of Batyl Alcohol and Isostearic Acid. The mixture of esters obtained from skin cond. agent – oc. 170754-20-8 the reaction of batyl alcohol with branched-chain stearic acids. Batyl Stearate an ester of Batyl Alcohol and stearic acid. The ester obtained from the reaction of skin cond. agent – oc. 13232-26-3 batyl alcohol with stearic acid. Behenyl Beeswax the ester of Behenyl Alcohol and Beeswax Acid. The mixture of esters obtained from skin cond. agent – oc. the reaction of behenyl alcohol with a mixture of straight-chain fatty acids, containing 24 to 36 carbons in alkyl chain length (beeswax acid). Behenyl Behenate the ester of Behenic Acid and Behenyl Alcohol. The ester obtained from the reaction skin cond. agent – oc. 17671-27-1 of behenic acid with behenyl alcohol. Behenyl Erucate the ester of Behenyl Alcohol and erucic acid. The ester obtained from the reaction of skin cond. agent – oc. 18312-32-8 behenyl alcohol with erucic acid. Behenyl Isostearate the ester of Behenyl Alcohol and isostearic acid that conforms to the formula. The skin cond. agent – oc. 181496-25-3 mixture of esters obtained from the reaction of behenyl alcohol with branched-chain stearic acids. Behenyl/Isostearyl Beeswax the ester of a mixture of Behenyl Alcohol and Isostearyl Alcohol with Beeswax Acid. skin cond. agent – oc. The mixture of esters obtained from the reaction of behenyl alcohol and branched- chain stearyl alcohols with a mixture of straight-chain fatty acids, containing 24 to 36 carbons in alkyl chain length (beeswax acid). Behenyl Olivate the ester of behenyl alcohol and Olive Acid that conforms generally to the formula. skin cond. agent – misc.; emul. The mixture of esters obtained from the reaction of behenyl alcohol with the fatty stabilizer; film former; slip modi- acids derived from olive acid. fier; visc, incr. agent – nonaq. Butyl Avocadate the ester of butyl alcohol and the fatty acids derived from Persea Grattisima skin cond. agent – misc. (Avocado) Oil. The mixture of esters obtained from the reaction of butyl alcohol with the fatty acids derived from Persea Grattisima (Avocado) Oil. Butyl Babassuate the ester of butyl alcohol and the fatty acids derived from babassu oil. The mixture of disp. agent-nonsurf.; emul. stab.; esters obtained from the reaction of butyl alcohol with the fatty acids derived from skin cond, agent -emol; surf.- babassu oil. solub. agent Butyl Isostearate the ester of butyl alcohol and isostearic acid that conforms to the formula. The skin cond, agent -emol mixture of esters obtained from the reaction of butyl alcohol with branched-chain stearic acids. Butyl Myristate the ester of butyl alcohol and myristic acid. The ester obtained from the reaction of skin cond, agent -emol 110-36-1 butyl alcohol with myristic acid. Butyl Oleate the ester of butyl alcohol and oleic acid. The ester obtained from the reaction of skin cond, agent –emol.; fragrance 142-77-8 butyl alcohol with oleic acid. ingr. Butyl Stearate the ester of butyl alcohol and stearic acid. The ester obtained from the reaction of skin cond, agent –emol.; fragrance 123-95-5 butyl alcohol and stearic acid. ingr. Butyloctyl Beeswax the ester of Butyloctanol and Beeswax Acid. The mixture of esters obtained from the skin cond. agent – oc. 151661-98-2 reaction of 2-butyloctanol with a mixture of straight-chain fatty acids, containing 24 to 36 carbons in alkyl chain length (beeswax acid). Butyloctyl Behenate the organic compound that conforms to the formula. The ester obtained from the skin cond. agent – emol. reaction of 2-butyloctanol with behenic acid. Butyloctyl Candelillate the ester of 2-butyloctanol and the acids derived from Euphorbia Cerifera skin cond. agent – oc. 226994-03-2 (Candelilla) Wax. The mixture of esters obtained from the reaction of 2-butyloctanol with the fatty acids derived from Euphorbia Cerifera (Candelilla) Wax. Butyloctyl Cetearate the ester of Butyloctanol and a blend of fatty acids containing predominantly palmitic skin cond. agent – emol. 101227-08-1 and stearic acid. The mixture of esters obtained from the reaction of 2-butyloctanol with a mixture of fatty acids containing predominately palmitic acid and stearic acid. Butyloctyl Oleate the ester of butyloctanol and oleic acid. The ester obtained from the reaction of skin cond. agent – oc. 2-butyloctanol with oleic acid. Butyloctyl Palmitate the ester of Butyloctanol and Palmitic Acid. The ester obtained from the reaction of skin cond. agent – emol. 2-butyloctanol with palmitic acid. C14-30 Alkyl Beeswax the ester of a mixture of fatty alcohols containing 14 to 30 carbons in the alkyl chain skin cond. agent – oc. 209225-40-1 with Beeswax Acid. The mixture of esters obtained from the reaction of a mixture of fatty alcohols, containing 14 to 30 carbons in the alkyl chain, with a mixture of straight-chain fatty acids, containing 24 to 36 carbons in alkyl chain (beeswax acid). C18-38 Alkyl Beeswax the ester of a mixture of fatty alcohols containing 18 to 38 carbon atoms in the alkyl skin cond. agent – oc. 223706-17-0 chain and Beeswax Acid. The mixture of esters obtained from the reaction of a mixture of fatty alcohols, containing 18 to 38 carbons in the alkyl chain, with a mixture of straight-chain fatty acids, containing 24 to 36 carbons in alkyl chain (beeswax acid). C30-50 Alkyl Beeswax the ester of C30-50 Alcohols and Beeswax Acid. The mixture of esters obtained skin cond. agent – oc. 223707-19-5 from the reaction of a mixture of fatty alcohols, containing 30 to 50 carbons in the alkyl chain, with a mixture of straight-chain fatty acids, containing 24 to 36 carbons in alkyl chain (beeswax acid). C20-40 Alkyl Behenate the ester of C20-40 Alcohols and behenic acid. The mixture of esters obtained from skin cond. agent – oc. the reaction of a mixture of fatty alcohols, containing 20 to 40 carbons in the alkyl chain, with behenic acid. 42

Table 5. Definitions and functions Ingredient/CAS No. Definition37 (italicized text generated by CIR) Function37 C18-38 Alkyl C24-54 Acid Ester the ester of a mixture of fatty alcohols containing 18 to 38 carbon atoms and a visc. incr. agent – nonaq. mixture of fatty acids containing 24 to 54 carbon atoms. The mixture of esters obtained from the reaction of a mixture of fatty alcohols, containing 30 to 50 carbons in the alkyl chain, with a mixture of straight-chain fatty acids, containing 24 to 54 carbons in alkyl chain. C16-36 Alkyl Stearate the ester of C16-36 alcohols and Stearic Acid. The mixture of esters obtained from skin cond. agent – oc. the reaction of a mixture of fatty alcohols, containing 16 to 36 carbons in the alkyl chain, with stearic acid. C20-40 Alkyl Stearate the ester of C20-40 Alcohols and stearic acid. The mixture of esters obtained from skin cond. agent – oc.; visc. incr. the reaction of a mixture of fatty alcohols, containing 20 to 40 carbons in the alkyl agent-aq. chain, with stearic acid. C30-50 Alkyl Stearate the ester of C30-50 Alcohols and Stearic Acid. The mixture of esters obtained from skin cond. agent – oc. the reaction of a mixture of fatty alcohols, containing 30 to 50 carbons in the alkyl chain, with stearic acid. C40-60 Alkyl Stearate the ester of C40-60 Alcohols and Stearic Acid. The mixture of esters obtained from skin cond. agent – oc. the reaction of a mixture of fatty alcohols, containing 40 to 60 carbons in the alkyl chain, with stearic acid. Caprylyl Butyrate the ester of n-octanol with butyric acid that conforms to the formula. The ester skin cond. agent – misc.; fragrance 110-39-4 obtained from the reaction of n-octanol with butyric acid. ingredient Caprylyl Caprylate the organic compound that conforms to the formula. The ester obtained from the skin cond. agent – emol. 2306-88-9 reaction of n-octanol with n-octanoic acid. Caprylyl Eicosenoate the organic compound that conforms to the formula. The ester obtained from the skin cond. agent – misc. reaction of n-octanol with 11-eicosenoic acid. Cetearyl Behenate the ester of Cetearyl Alcohol and Behenic Acid. The mixture of esters obtained from skin cond. agent – oc. the reaction of a mixture of fatty alcohols, containing 16 to 18 carbons in the alkyl chain, with behenic acid. Cetearyl Candelillate the ester of Cetearyl Alcohol and the fatty acids derived from Euphorbia Cerifera skin cond. agent – oc. (Candelilla) Wax. The mixture of esters obtained from the reaction of a mixture of fatty alcohols, containing 16 to 18 carbons in the alkyl chain, with the fatty acids derived from Euphorbia Cerifera (Candelilla) Wax. Cetearyl Isononanoate the ester of cetearyl alcohol and a branched chain nonanoic acid. The mixture of skin cond. agent-emol.; hair cond. esters obtained from the reaction of a mixture of fatty alcohols, containing 16 to 18 agent carbons in the alkyl chain, with branched chain nonanoic acid. Cetearyl Nonanoate the organic compound that conforms to the formula. The mixture of esters obtained skin cond. agent-emol. 878027-13-5 from the reaction of a mixture of fatty alcohols, containing 16 to 18 carbons in the alkyl chain, with nonanoic acid. Cetearyl Olivate the ester of Cetearyl Alcohol and the fatty acids derived from olive oil. The mixture hair cond. agent of esters obtained from the reaction of a mixture of fatty alcohols, containing 16 - 18 carbons in the alkyl chain, with the fatty acids derived from olive oil. Cetearyl Palmate the ester of Cetearyl Alcohol and Palm Acid. The mixture of esters obtained from the skin cond. agent – emol.; emul. reaction of a mixture of fatty alcohols, containing 16 to 18 carbons in the alkyl chain, stab. with the fatty acids derived from palm acid. Cetearyl Palmitate the ester of Cetearyl Alcohol and palmitic acid. The mixture of esters obtained from skin cond. agent-emol.; hair cond. 85341-79-3 the reaction of a mixture of fatty alcohols, containing 16 to 18 carbons in the alkyl agent chain, with palmitic acid. Cetearyl Rice Branate the ester of Cetearyl Alcohol and Rice Bran Acid. The mixture of esters obtained skin cond. agent – misc. from the reaction of a mixture of fatty alcohols, containing 16 to 18 carbons in the alkyl chain, with the fatty acids derived from rice bran acid. Cetearyl Stearate the ester of Cetearyl Alcohol and stearic acid. The mixture of esters obtained from skin cond. agent – oc. 93820-97-4 the reaction of a mixture of fatty alcohols, containing 16 to 18 carbons in the alkyl chain, with stearic acid. Cetyl Babassuate the ester of cetyl alcohol and the fatty acids derived from Orbignya Oleifera skin cond. agent – emol.; visc. 613236-40-1 (Babassu) Oil. The mixture of esters obtained from the reaction of cetyl alcohol with incr. agent-aq. the fatty acids derived from Orbignya Oleifera (Babassu) Oil. Cetyl Behenate the ester of that conforms to the formula. The ester obtained from the reaction of skin cond. agent – oc. 42233-11-4 cetyl alcohol with behenic acid. Cetyl Caprate the ester of cetyl alcohol and capric acid. The ester obtained from the reaction of skin cond. agent – emol. cetyl alcohol with capric acid. Cetyl Caprylate the ester of cetyl alcohol and caprylic acid. The ester obtained from the reaction of skin cond. agent – emol. 29710-31-4 cetyl alcohol with caprylic acid. Cetyl Dimethyloctanoate the ester of cetyl alcohol and dimethyloctanoic acid. The ester obtained from the skin cond. agent – emol. reaction of cetyl alcohol with dimethyloctanoic acid. Cetyl Esters a synthetic wax intended to be indistinguishable from natural spermaceti wax with skin cond. agent– emol. regard to composition and properties. It consists of a mixture of esters of 14 to 18 carbon fatty acids and alcohols. The mixture of esters obtained from the reaction of a mixture of fatty alcohols, containing 14 to 18 carbons in the alkyl chain, with a mixture of straight-chain fatty acids, containing 14 to 18 carbons in the alkyl chain. Cetyl Isononanoate the ester of cetyl alcohol with a branched chain nonanoic acid. The mixture of esters skin cond. agent – emol. 84878-33-1 obtained from the reaction of cetyl alcohol with branched-chain nonanoic acids. Cetyl Laurate the ester of cetyl alcohol and lauric acid that conforms to the formula. The ester skin cond. agent – emol. 20834-06-4 obtained from the reaction of cetyl alcohol with lauric acid. Cetyl Myristate the ester of cetyl alcohol and myristic acid. The ester obtained from the reaction of skin cond. agent – oc. 2599-01-1 cetyl alcohol and myristic acid. 43

Table 5. Definitions and functions Ingredient/CAS No. Definition37 (italicized text generated by CIR) Function37 Cetyl Myristoleate the ester of Cetyl Alcohol and myristoleic acid that conforms to the formula. The skin cond. agent – misc. ester obtained from the reaction of cetyl alcohol and myristoleic acid. Cetyl Oleate the ester of cetyl alcohol and oleic acid. The ester obtained from the reaction of cetyl skin cond. agent – emol. 22393-86-8 alcohol with oleic acid. Cetyl Palmitate the ester of cetyl alcohol and palmitic acid. The ester obtained from the reaction of skin cond, agent –oc.; fragrance 540-10-3 cetyl alcohol with palmitic acid. ingr. Cetyl Ricinoleate the ester of cetyl alcohol and ricinoleic acid. The ester obtained from the reaction of skin cond. agent – oc. 10401-55-5 cetyl alcohol with ricinoleic acid. Cetyl Stearate the ester of cetyl alcohol and stearic acid. The ester obtained from the reaction of skin cond. agent – oc. 1190-63-2 cetyl alcohol with stearic acid. Cetyl Tallowate the ester of Cetyl Alcohol and Tallow Acid. The mixture of esters obtained from the skin cond. agent – misc. reaction of cetyl alcohol with the fatty acids derived from tallow acid. Chimyl Isostearate the ester of Chimyl Alcohol and isostearic acid. The mixture of esters obtained from skin cond. agent – emol. the reaction of cetyl glyceryl ether with branched-chain stearic acids. Chimyl Stearate the ester of Chimyl Alcohol and stearic acid. The ester obtained from the reaction of skin cond. agent – emol. 131932-18-8 cetyl glyceryl ether with stearic acid. C10-40 Isoalkyl Acid a mixture of esters of Octyldodecanol with branched-chain alkyl acids containing 10 skin cond. agent – misc.; visc. Octyldodecanol Esters to 40 carbons. The mixture of esters obtained from the reaction of 2-octyldodecanol incr. agent-nonaq. with branched-chain fatty acids, containing 10 to 40 carbons in the alkyl chain. C4-5 Isoalkyl Cocoate the ester of a branched, saturated fatty alcohol containing 4 to 5 carbons, with skin cond. agent – emol. Coconut Acid. The mixture of esters obtained from the reaction of branched-chain alcohols, containing 4 to 5 carbons, with the fatty acids derived from coconut acid. C32-36 Isoalkyl Stearate the ester of a branched, saturated fatty alcohol containing 32 to 36 carbons, with skin cond. agent – emol. 68201-22-9 stearic acid. The mixture of esters obtained from the reaction of branched-chain alcohols, containing 32 to 36 carbons, with stearic acid. Coco-Caprylate the organic compound that conforms to the formula. The mixture of esters obtained skin cond. agent – emol. from the reaction of the fatty alcohols derived from coconut alcohol with caprylic acid. Coco-Caprylate/Caprate a mixture of esters of Coconut Alcohol with Caprylic Acid and Capric Acid. The skin cond. agent – emol. mixture of esters obtained from the reaction of the fatty alcohols derived from coconut alcohol with a mixture of caprylic acid and capric acid. Coco-Rapeseedate the ester of Coconut Alcohol and the fatty acids derived from Brassica Campestris skin cond. agent – emol. (Rapeseed) Oil. The mixture of esters obtained from the reaction of the fatty alcohols derived from coconut alcohol with the fatty acids derived from Brassica Campestris (Rapeseed) Oil. Decyl Castorate the ester of Decyl Alcohol and the fatty acids derived from Ricinus Communis skin cond. agent – emol.; emul. (Castor) Oil. The mixture of esters obtained from the reaction of decyl alcohol with stab. the fatty acids derived from Ricinus Communis (Castor) Oil. Decyl Cocoate the ester of Decyl Alcohol and the fatty acids derived from Cocos Nucifera skin cond. agent – oc. (Coconut) Oil. The mixture of esters obtained from the reaction of decyl alcohol with the fatty acids derived from Cocos Nucifera (Coconut) Oil. Decyl Isostearate the ester of decyl alcohol and isostearic acid. The mixture of esters obtained from the skin cond. agent – emol. 84605-08-3 reaction of decyl alcohol with branched-chain stearic acids. Decyl Jojobate the ester of decyl alcohol and the fatty acids derived from Simmondsia Chinensis skin cond. agent – emol. (Jojoba) Oil. The mixture of esters obtained from the reaction of decyl alcohol with the fatty acids derived from Simmondsia Chinensis (Jojoba) Oil. Decyl Laurate the organic compound that conforms to the formula. The ester obtained from the skin cond. agent – emol. 36528-28-6 reaction of decyl alcohol with lauric acid. Decyl Myristate the ester of decyl alcohol and myristic acid that conforms to the formula. The ester skin cond. agent – oc. 41927-71-3 obtained from the reaction of decyl alcohol with myristic acid. Decyl Oleate the ester of decyl alcohol and oleic acid. The ester obtained from the reaction of skin cond. agent – emol. 3687-46-5 decyl alcohol with oleic acid. Decyl Olivate the ester of Decyl Alcohol and the fatty acids derived from Olea Europea (Olive) Oil. skin cond. agent – oc. The mixture of esters obtained from the reaction of decyl alcohol with the fatty acids derived from Olea Europea (Olive) Oil. Decyl Palmitate the ester of decyl alcohol and palmitic acid that conforms to the formula. The ester skin cond. agent – emol. 42232-27-9 obtained from the reaction of decyl alcohol with palmitic acid. Decyltetradecyl Cetearate the ester of Decyltetradecanol and a blend of fatty acids containing predominantly skin cond. agent – emol. 97404-34-7 palmitic and stearic acid. The mixture of esters obtained from the reaction of 2-decyltetradecanol with a mixture of fatty acids, containing predominantly palmitic acid and stearic acid. Ethylhexyl Adipate/Palmitate/ a mixture of esters formed by the reaction of 2-ethylhexyl alcohol with adipic, skin cond. agent-emol. Stearate palmitic, and stearic acids. Ethylhexyl C10-40 Isoalkyl the ester of C10-40 Isoalkyl Acid and 2-ethylhexyl alcohol. The mixture of esters skin cond. agent-misc.; visc. incr. Acidate obtained from the reaction of 2-ethylhexyl alcohol with branched-chain acids, agent-nonaq. containing 10 to 40 carbons in the alkyl chain. Ethylhexyl Cocoate the ester of 2-ethylhexanol and Coconut Acid that conforms to the formula. The skin cond. agent-emol. 91052-62-9;92044-87-6 mixture of esters obtained from the reaction of 2-ethylhexyl alcohol with the fatty acids derived from coconut acid. Ethylhexyl Hydroxystearate the ester of 2-ethylhexyl alcohol and 12-hydroxystearic acid. The ester obtained skin cond. agent-emol. 29383-26-4; 29710-25-6 from the reaction of 2-ethylhexyl alcohol with 12-hydroxystearic acid.

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Table 5. Definitions and functions Ingredient/CAS No. Definition37 (italicized text generated by CIR) Function37 Ethylhexyl Isononanoate the ester of 2-ethylhexyl alcohol and a branched chain nonanoic acid. The mixture of skin cond. agent-emol. 70969-70-9; 71566-49-9 esters obtained from the reaction of 2-ethylhexyl alcohol with branched-chain nonanoic acids. Ethylhexyl Isopalmitate the ester of 2-ethylhexanol and a branched chain 16 carbon aliphatic acid. The skin cond. agent-emol. 93843-32-4 mixture of esters obtained from the reaction of 2-ethylhexanol with branched-chain palmitic acids. Ethylhexyl Isostearate the ester of 2-ethylhexyl alcohol and isostearic acid. The mixture of esters obtained skin cond. agent-emol. 81897-25-8; 85186-76-1 from the reaction of 2-ethylhexyl alcohol with branched-chain stearic acids. Ethylhexyl Laurate the ester of 2-ethylhexyl alcohol and lauric acid. The ester obtained from the skin cond. agent-emol. 20292-08-4 reaction of 2-ethylhexyl alcohol with lauric acid. Ethylhexyl Myristate the ester of 2-ethylhexyl alcohol and myristic acid. The ester obtained from the skin cond. agent-emol. 29806-75-5 reaction of 2-ethylhexyl alcohol with myristic acid. Ethylhexyl Neopentanoate ester of 2-ethylhexanol and neopentanoic acid. The ester obtained from the reaction skin cond. agent-emol. of 2-ethylhexanol with neopentanoic acid. Ethylhexyl Oleate the ester of oleic acid and 2-ethyl hexyl alcohol. The ester obtained from the skin cond. agent-emol. 26399-02-0 reaction of 2-ethylhexyl alcohol with oleic acid. Ethylhexyl Olivate the ester of ethylhexyl alcohol and the fatty acids derived from Olea Europaea skin cond. agent-oc. (Olive) Oil. The mixture of esters obtained from the reaction of 2-ethylhexyl alcohol with the fatty acids derived from Olea Europaea (Olive) Oil. Ethylhexyl Palmitate the ester of 2-ethylhexyl alcohol and palmitic acid. The ester obtained from the skin cond. agent-emol.; fragrance 29806-73-3 reaction of 2-ethylhexyl alcohol with palmitic acid. ingr. Ethylhexyl Pelargonate the ester of 2-ethylhexyl alcohol and Pelargonic Acid. The ester obtained from the skin cond. agent-emol. 59587-44-9 reaction of 2-ethylhexyl alcohol with pelargonic acid. Ethylhexyl Stearate the ester of 2-ethylhexyl alcohol and stearic acid. The ester obtained from the skin cond. agent-emol. 22047-49-0 reaction of 2-ethylhexyl alcohol with stearic acid. Erucyl Arachidate the ester of erucyl alcohol and Arachidic Acid. The ester obtained from the reaction skin cond. agent-misc. of erucyl alcohol with arachidic acid. Erucyl Erucate the ester of erucyl alcohol and erucic acid. The ester obtained from the reaction of skin cond. agent-misc. 27640-89-7; 84605-12-9 erucyl alcohol with erucic acid. Erucyl Oleate the ester of erucyl alcohol and oleic acid that conforms to the formula. The ester skin cond. agent-misc. 85617-81-8 obtained from the reaction of erucyl alcohol with oleic acid. Heptyl Undecylenate the organic compound that conforms to the formula. The ester obtained from the skin cond. agent-emol. 68141-27-5 reaction of heptyl alcohol with 10-undecenoic acid. Heptylundecyl Hydroxystearate the organic compound that conforms to the formula. The ester obtained from the skin cond. agent-emol. 74659-69-1 reaction of 2-heptylundecyl alcohol with 12-hydroxystearate. Hexyldecyl Hexyldecanoate the ester that conforms to the formula. The ester obtained from the reaction of skin cond. agent-emol. 2-hexyldecanol with 2-hexyldecanoic acid. Hexyldecyl Isostearate the ester of hexyldecyl alcohol and isostearic acid. The mixture of esters obtained skin cond. agent-oc. 69247-84-3 from the reaction of 2-hexyldecyl alcohol with branched-chain stearic acids. Hexyldecyl Laurate the ester of hexyldecanol and lauric acid. The ester obtained from the reaction of skin cond. agent-emol.; skin cond. 34362-27-1; 227450-65-9 2-hexyldecanol with lauric acid. agent-oc. Hexyldecyl Oleate the ester of Hexyldecanol and oleic acid. The ester obtained from the reaction of skin cond. agent-oc. 94278-07-6 2-hexyldecanol with oleic acid. Hexyldecyl Palmitate the ester of Hexyldecanol and palmitic acid that conforms to the formula. The ester skin cond. agent-oc. 69275-02-1 obtained from the reaction of 2-hexyldecanol with palmitic acid. Hexyldecyl Stearate the ester of Stearic Acid and Hexyldecanol. The ester obtained from the reaction of skin cond. agent-emol.; skin cond. 17618-45-0 2-hexyldecanol with stearic acid. agent-oc. Hexyldodecyl/Octyldecyl the product formed by the reaction of Hexyldodecanol and Octyldecanol with skin cond. agent-emol. Hydroxystearate Hydroxystearic Acid. The mixture of esters obtained from the reaction of a mixture of 2-hexyldodecanol and 2-octyldecanol with 12-hydroxystearic acid. Hexyl Isostearate the ester of hexyl alcohol and isostearic acid that conforms to the formula. The skin cond. agent-emol. 94247-25-3 mixture of esters obtained from the reaction of hexyl alcohol with branched-chain stearic acids. Hexyl Laurate the ester of hexyl alcohol and lauric acid. The ester obtained from the reaction of skin cond. agent-emol. 34316-64-8 hexyl alcohol with lauric acid. Hydrogenated Castor Oil Behenyl the hydrogenation product of the esters formed by the reaction of castor oil and hair cond. agent; binder; emul. Esters behenyl alcohol. The hydrogenation product of the mixture of esters obtained from stab. the reaction of behenyl alcohol with castor oil. Hydrogenated Castor Oil Cetyl the hydrogenation product of the esters formed by the reaction of castor oil with cetyl skin cond. agent-misc.; hair cond. Esters alcohol. The hydrogenation product of the mixture of esters obtained from the agent; binder; emul. stab. reaction of cetyl alcohol with castor oil. Hydrogenated Castor Oil Stearyl the hydrogenation product of the esters formed by the reaction of castor oil and skin cond. agent-misc.; hair cond. Esters stearyl alcohol. The hydrogenation product of the mixture of esters obtained from the agent; binder; emul. stab. reaction of stearyl alcohol with castor oil. Hydrogenated Ethylhexyl Olivate a mixture of esters produced by the reaction of ethylhexanol and Hydrogenated Olive skin cond. agent-emol. Oil. The mixture of esters obtained from the reaction of 2-ethylhexyl alcohol with hydrogenated olive oil. Hydrogenated Ethylhexyl the product of the transesterification of 2-ethylhexyl alcohol and sesame seed oil that skin cond. agent-emol.; binder Sesamate has been hydrogenated. The mixture of esters obtained from the reaction of 2-ethylhexyl alcohol with hydrogenated sesame seed oil.

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Table 5. Definitions and functions Ingredient/CAS No. Definition37 (italicized text generated by CIR) Function37 Hydrogenated Isocetyl Olivate the end-product of the controlled hydrogenation of the mixture of esters formed by skin cond. agent-misc.; binder; the reaction of isocetyl alcohol with olive acid. The hydrogenation product of the disp. agent; humectant mixture of esters obtained from the reaction of branched-chain cetyl alcohols with the fatty acids derived from olive acid. Hydrogenated Isopropyl Jojobate the end-product of the controlled hydrogenation of Isopropyl Jojobate. The skin cond. agent-oc. hydrogenation product of the mixture of esters obtained from the reaction of iso- propyl alcohol with the fatty acids derived from Simmondsia Chinensis (Jojoba) Oil. Hydroxycetyl Isostearate the ester of hydroxycetyl alcohol and isostearic acid. The mixture of esters obtained skin cond. agent-emol. from the reaction of cetyl glycol with branched-chain stearic acids. Hydroxyoctacosanyl Hydroxy- the ester of hydroxyoctacosanyl alcohol and hydroxystearic acid. The ester obtained skin cond. agent-emol.; visc. incr. stearate from the reaction of 2-hydroxyoctacosanyl alcohol with 12-hydroxystearic acid. agent 93840-71-2 Isoamyl Laurate the ester of isoamyl alcohol and lauric acid. The ester obtained from the reaction of skin cond. agent-emol.; fragrance 6309-51-9 isoamyl alcohol with lauric acid. ingr. Isobutyl Myristate the ester of isobutyl alcohol and myristic acid. The ester obtained from the reaction skin cond. agent-emol. 25263-97-2 of isobutyl alcohol with myristic acid. Isobutyl Palmitate the ester of isobutyl alcohol and palmitic acid. The ester obtained from the reaction skin cond. agent-emol.; fragrance 110-34-9 of isobutyl alcohol with palmitic acid. ingr. Isobutyl Pelargonate the ester of isobutyl alcohol and Pelargonic Acid. The ester obtained from the skin cond. agent-emol.; fragrance 30982-03-7 reaction of isobutyl alcohol with nonanoic acid. ingr. Isobutyl Stearate the ester of isobutyl alcohol and stearic acid. The ester obtained from the reaction of skin cond. agent-emol. 646-13-9 isobutyl alcohol with stearic acid Isobutyl Tallowate the ester of isobutyl alcohol and Tallow Acid. The mixture of esters obtained from skin cond. agent-emol. 68526-50-1 the reaction of isobutyl alcohol with the fatty acids derived from tallow acid. Isocetyl Behenate the ester of Isocetyl Alcohol and behenic acid. The mixture of esters obtained from skin cond. agent-oc. 94247-28-6 the reaction of branched-chain cetyl alcohols with behenic acid. Isocetyl Isodecanoate the mixture of esters obtained from the reaction of isocetyl alcohol with a branched, skin cond. agent-emol. 129588-05-2 fatty acid, containing 10 carbons in the alkyl chain. The mixture of esters obtained from the reaction of branched-chain cetyl alcohols with branched-chain decanoic acids. Isocetyl Isostearate the ester of isocetyl alcohol and isostearic acid. The mixtures of esters obtained from skin cond. agent-emol. 52006-45-8 the reaction of branched-chain cetyl alcohols with branched-chain stearic acids. Isocetyl Laurate the ester of isocetyl alcohol and lauric acid. The mixture of esters obtained from the skin cond. agent-emol. 89527-28-6 reaction of branched-chain cetyl alcohols with lauric acid. Isocetyl Myristate the ester of Isocetyl Alcohol and myristic acid. The mixture of esters obtained from skin cond. agent-oc. 83708-66-1 the reaction of branched-chain cetyl alcohols with myristic acid. Isocetyl Palmitate the ester of Isocetyl Alcohol and palmitic acid. The mixture of esters obtained from skin cond. agent-emol. 127770-27-8 the reaction of branched-chain cetyl alcohols with palmitic acid. Isocetyl Stearate the ester of isocetyl alcohol and stearic acid. The mixture of esters obtained from the skin cond. agent-emol. 25339-09-7 reaction of branched-chain cetyl alcohols with stearic acid. Isodecyl Cocoate the ester of branched chain decyl alcohols and coconut acid. The mixture of esters skin cond. agent-emol. obtained from the reaction of branched-chain decyl alcohols with the fatty acids derived from coconut acid. Isodecyl Hydroxystearate the ester of branched chain decyl alcohols and 12-hydroxystearic acid. The mixture skin cond. agent-emol. 29383-27-5; 59231-36-6 of esters obtained from the reaction of branched-chain decyl alcohols with 12-hydroxystearic acid. Isodecyl Isononanoate the ester of branched chain decyl alcohols and a branched chain nonanoic acid. The skin cond. agent-emol. 41395-89-5; 59231-35-5 mixture of esters obtained from the reaction of branched-chain decyl alcohols with branched-chain nonanoic acids. Isodecyl Laurate the ester of branched chain decyl alcohols and lauric acid. The mixture of esters skin cond. agent-emol. 14779-93-2; 94247-10-6 obtained from the reaction of branched-chain decyl alcohols with lauric acid. Isodecyl Myristate the ester of branched chain decyl alcohols and myristic acid. The mixture of esters skin cond. agent-emol. 17670-91-6; 51473-24-6 obtained from the reaction of branched-chain decyl alcohols with myristic acid. Isodecyl Neopentanoate the ester of branched chain decyl alcohols and neopentanoic acid. The mixture of skin cond. agent-emol. 60209-82-7 esters obtained from the reaction of branched-chain decyl alcohols with neopentanoic acid. Isodecyl Oleate the ester of branched chain decyl alcohols and oleic acid. The mixture of esters skin cond. agent-emol. 59231-34-4 obtained from the reaction of branched-chain decyl alcohols with oleic acid. Isodecyl Palmitate the ester of branched chain decyl alcohols and palmitic acid. The mixture of esters skin cond. agent-emol. 14779-95-4; 59231-33-3 obtained from the reaction of branched-chain decyl alcohols with palmitic acid. Isodecyl Stearate the ester of branched decyl alcohols and stearic acid. The mixture of esters obtained skin cond. agent-emol. 31565-38-5 from the reaction of branched-chain decyl alcohols with stearic acid. Isohexyl Caprate the ester of capric acid and a branched chain, 6-carbon alcohol. The mixture of esters skin cond. agent-emol. obtained from the reaction of branched-chain hexyl alcohols with capric acid. Isohexyl Laurate the ester of a branched chain hexyl alcohol and lauric acid. The mixture of esters skin cond. agent-emol. 59219-73-7 obtained from the reaction of branched-chain hexyl alcohols with lauric acid. Isohexyl Neopentanoate the ester of isohexyl alcohol and neopentanoic acid that conforms to the formula. skin cond. agent-emol. 131141-70-3; 150588-62-8 The mixture of esters obtained from the reaction of branched-chain hexyl alcohols with neopentanoic acid. Isohexyl Palmitate the ester of a branched chain hexyl alcohol and palmitic acid. The mixture of esters skin cond. agent-emol. 55194-91-7; 59219-72-6 obtained from the reaction of branched-chain hexyl alcohols with palmitic acid.

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Table 5. Definitions and functions Ingredient/CAS No. Definition37 (italicized text generated by CIR) Function37 Isolauryl Behenate the ester of branched chain dodecyl alcohols and behenic acid. The mixture of esters skin cond. agent-oc. obtained from the reaction of branched-chain lauryl alcohols with behenic acid. Isononyl Isononanoate the ester of a branched chain nonyl alcohol with a branched chain nonanoic acid. The skin cond. agent-emol. 42131-25-9; 59219-71-5 mixture of esters obtained from the reaction of branched-chain nonyl alcohols with branched-chain nonanoic acids. Isooctyl Caprylate/Caprate the ester of a branched chain octyl alcohol with a mixture of caprylic and capric skin cond. agent-emol.; acids. The mixture of esters obtained from the reaction of branched-chain octyl antioxidant alcohols with a mixture of caprylic and capric acids. Isooctyl Tallate the organic compound that conforms to the formula. The mixture of esters obtained skin cond. agent-emol.; plasticizer; from the reaction of branched-chain octyl alcohols with the fatty acids derived from solvent tall oil. Isopropyl Arachidate the ester of isopropyl alcohol and Arachidic Acid that conforms to the formula. The skin cond. agent-emol. 26718-90-1 ester obtained from the reaction of isopropyl alcohol with arachidic acid. Isopropyl Avocadate the ester of isopropyl alcohol and the fatty acids derived from avocado oil. The skin cond. agent-emol. 90990-05-9 mixture of esters obtained from the reaction of isopropyl alcohol with the fatty acids derived from avocado oil. Isopropyl Babassuate the ester of isopropyl alcohol and the fatty acids derived from Orbignya Oleifera skin cond. agent-emol.; binder; (Babassu) Oil. The mixture of esters obtained from the reaction of isopropyl alcohol disp. agent-non-surf; emul. stab. with the fatty acids derived from Orbignya Oleifera (Babassu) Oil. Isopropyl Behenate the ester of isopropyl alcohol and Behenic Acid. The ester obtained from the skin cond. agent-emol. 26718-95-6 reaction of isopropyl alcohol with behenic acid. Isopropyl Hydroxystearate the ester of isopropyl alcohol and 12-hydroxystearic acid. The ester obtained from skin cond. agent-emol. the reaction of isopropyl alcohol with 12-hydroxystearic acid. Isopropyl Isostearate the ester of isopropyl alcohol and isostearic acid. The mixture of esters obtained skin cond. agent-emol.; binder 31478-84-9; 68171-33-5 from the reaction of isopropyl alcohol with branched-chain stearic acids. Isopropyl Jojobate the ester of isopropyl alcohol and the acids derived from Simmondsia Chinensis skin cond. agent-emol. (Jojoba) Oil. The mixture of esters obtained from the reaction of isopropyl alcohol with the fatty acids derived from Simmondsia Chinensis (Jojoba) Oil. Isopropyl Laurate the ester of isopropyl alcohol and lauric acid. The ester obtained from the reaction skin cond. agent-emol.; binder; 10233-13-3 of isopropyl alcohol with lauric acid. fragrance ingr. Isopropyl Linoleate the ester of isopropyl alcohol and linoleic acid. The ester obtained from the reaction skin cond. agent-emol. 22882-95-7 of isopropyl alcohol with linoleic acid. Isopropyl Myristate the ester of isopropyl alcohol and myristic acid. The ester obtained from the reaction skin cond. agent-emol.; binder; 110-27-0 of isopropyl alcohol with myristic acid. fragrance ingr. Isopropyl Oleate the ester of isopropyl alcohol and oleic acid. The ester obtained from the reaction of skin cond. agent-emol.; binder 112-11-8; 17364-07-7 isopropyl alcohol with oleic acid. Isopropyl Palmitate the ester of isopropyl alcohol and palmitic acid. The ester obtained from the reaction skin cond. agent-emol.; binder; 142-91-6 of isopropyl alcohol with myristic acid. fragrance ingr. Isopropyl Ricinoleate the ester of isopropyl alcohol and ricinoleic acid. The ester obtained from the skin cond. agent-emol. 71685-99-9 reaction of isopropyl alcohol with ricinoleic acid. Isopropyl Sorbate the ester of isopropyl alcohol and sorbic acid. The ester obtained from the reaction preservative 44987-75-9; 55584-26-4 of isopropyl alcohol with sorbic acid. Isopropyl Stearate the ester of isopropyl alcohol and stearic acid. The ester obtained from the reaction skin cond. agent-emol.; binder 112-10-7 of isopropyl alcohol with stearic acid. Isopropyl Tallowate the ester of isopropyl alcohol and Tallow Acid. The mixture of esters obtained from skin cond. agent-emol.; binder the reaction of isopropyl alcohol with the fatty acids derived from tallow acid. Isostearyl Avocadate the ester of Isostearyl Alcohol and the acids derived from avocado oil. The mixture skin cond. agent-emol. 90990-06-0 of esters obtained from the reaction of branched-chain stearic alcohols with the fatty acids derived from avocado oil. Isostearyl Behenate the ester of Isostearyl Alcohol and Behenic Acid. The mixture of esters obtained skin cond. agent-oc. 125804-16-2 from the reaction of branched-chain stearic alcohols with behenic acid. Isostearyl Erucate the ester of Isostearyl Alcohol and erucic acid. The mixture of esters obtained from skin cond. agent-oc. 84605-10-7 the reaction of branched-chain stearyl alcohols with erucic acid. Isostearyl Hydroxystearate the ester of isostearyl alcohol and hydroxystearic acid. The mixture of esters ob- skin cond. agent-emol. 162888-05-3; 338450-67-2 tained from the reaction of branched-chain stearyl alcohols with 12-hydroxystearic acid. Isostearyl Isononanoate the ester of isostearyl alcohol and isononanoic acid. The mixture of esters obtained skin cond. agent-emol. 90967-66-1; 163564-45-2 from the reaction of branched-chain stearyl alcohols with branched-chain nonanoic acids. Isostearyl Isostearate the ester of Isostearyl Alcohol and Isostearic Acid. The mixture of esters obtained skin cond. agent-emol.; binder 41669-30-1 from the reaction of branched-chain stearyl alcohols with branched-chain stearic acids. Isostearyl Laurate the ester of isostearyl alcohol and lauric acid. The mixture of esters obtained from skin cond. agent-emol. the reaction of branched-chain stearyl alcohols with lauric acid Isostearyl Linoleate the ester of isostearyl alcohol and linoleic acid. The mixture of esters obtained from skin cond. agent-emol. 127358-80-9 the reaction of branched-chain stearyl alcohols with linoleic acid. Isostearyl Myristate the ester of isostearyl alcohol and myristic acid. The mixture of esters obtained from skin cond. agent-emol.; binder 72576-81-9 the reaction of branched-chain stearyl alcohols with myristic acid. Isostearyl Neopentanoate the ester of isostearyl alcohol and neopentanoic acid. The mixture of esters obtained skin cond. agent-emol.; binder 58958-60-4 from the reaction of branched-chain stearyl alcohols with neopentanoic acid. Isostearyl Palmitate the ester of Isostearyl Alcohol and palmitic acid. The mixture of esters obtained from skin cond. agent-emol.; binder 69247-83-2; 72576-80-8 the reaction of branched-chain stearyl alcohols with palmitic acid.

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Table 5. Definitions and functions Ingredient/CAS No. Definition37 (italicized text generated by CIR) Function37 Isotridecyl Isononanoate the ester of isotridecyl alcohol and isononanoic acid. The mixture of esters obtained skin cond. agent-emol. 42131-27-1; 59231-37-7 from the reaction of branched-chain tridecyl alcohols with branched-chain nonanoic acids. Isotridecyl Laurate the ester of Isotridecyl Alcohol and lauric acid that conforms generally to the skin cond. agent-oc.; hair cond. 94134-83-5 formula. The mixture of esters obtained from the reaction of branched-chain tridecyl agent alcohols with lauric acid. Isotridecyl Myristate The ester of myristic acid and isotridecyl alcohol. The mixture of esters obtained skin cond. agent-oc.; hair cond. 96518-24-0 from the reaction of branched-chain tridecyl alcohols with myristic acid. agent Isotridecyl Stearate the monoester of isotridecyl alcohol and stearic acid that conforms to the formula. skin cond. agent-emol. 31565-37-4 The mixture of esters obtained from the reaction of branched-chain tridecyl alcohols with stearic acid. Lauryl Behenate the ester of lauryl alcohol and behenic acid. The ester obtained from the reaction of skin cond. agent-oc. 42233-07-8 lauryl alcohol with behenic acid. Lauryl Cocoate the ester of lauryl alcohol and the fatty acids derived from coconut oil. The mixture skin cond. agent-emol.; skin cond. of esters obtained from the reaction of lauryl alcohol with the fatty acids derived agent-oc. from coconut oil. Lauryl Isostearate the ester of lauryl alcohol and Isostearic Acid. The mixture of esters obtained from skin cond. agent-emol. 93803-85-1 the reaction of lauryl alcohol with branched-chain stearic acids. Lauryl Laurate the ester of Lauryl Alcohol and Lauric Acid. The ester obtained from the reaction of skin cond. agent-misc.; binder; 13945-76-1 lauryl alcohol with lauric acid. emul. stab.; hair cond. agent; opacifying agent Lauryl Myristate the ester of lauryl alcohol and myristic acid. The ester obtained from the reaction of skin cond. agent-oc.; hair cond. 2040-64-4 lauryl alcohol with myristic acid. agent Lauryl Oleate ester of lauryl alcohol and oleic acid that conforms to the formula. The ester skin cond. agent-oc. 36078-10-1 obtained from the reaction of lauryl alcohol with oleic acid. Lauryl Palmitate the ester of lauryl alcohol and palmitic acid. The ester obtained from the reaction of skin cond. agent-oc. 42232-29-1 lauryl alcohol with palmitic acid. Lauryl Stearate the ester of lauryl alcohol and stearic acid. The ester obtained from the reaction of skin cond. agent-oc. 5303-25-3 lauryl alcohol with stearic acid. Lignoceryl Erucate the ester of lignoceryl alcohol and erucic acid. The ester obtained from the reaction skin cond. agent-emol. of lignoceryl alcohol with erucic acid. Myristyl Isostearate the ester of myristyl alcohol and isostearic acid. The mixture of esters obtained from skin cond. agent-emol. 94247-26-4 the reaction of myristyl alcohol with branched-chain stearic acids. Myristyl Laurate the ester of myristyl alcohol and lauric acid. The ester obtained from the reaction of surf-emulsifying agent 22412-97-1 myristyl alcohol with lauric acid. Myristyl Myristate the ester of myristyl alcohol and myristic acid. The ester obtained from the reaction skin cond. agent-oc. 3234-85-3 of myristyl alcohol with myristic acid Myristyl Neopentanoate the ester of myristyl alcohol and neopentanoic acid. The ester obtained from the skin cond. agent-emol. 144610-93-5 reaction of myristyl alcohol with neopentanoic acid. Myristyl Stearate the ester of myristyl alcohol and stearic acid. The ester obtained from the reaction of skin cond. agent-oc. 17661-50-6 myristyl alcohol and stearic acid. Octyldecyl Oleate the ester of octyldecanol and oleic acid. The ester obtained from the reaction of 2- skin cond. agent-emol. octyldecanol with oleic acid. Octyldodecyl Avocadoate the ester of Octyldodecanol and the fatty acids derived from avocado oil. The skin cond. agent-emol. mixture of esters obtained from the reaction of 2-octyldodecanol with the fatty acids derived from avocado oil. Octyldodecyl Beeswax the ester of Octyldodecanol and Beeswax Acid. The mixture of esters obtained from skin cond. agent-emol. the reaction of 2-octyldodecanol with a mixture of straight-chain fatty acids, containing 24 to 36 carbons in alkyl chain length (beeswax acid). Octyldodecyl Behenate the ester of Octyldodecanol and behenic acid that conforms to the formula. The ester skin cond. agent-oc. 125804-08-2 obtained from the reaction of 2-octyldodecanol with behenic acid. Octyldodecyl Cocoate the ester of octyldodecanol and coconut acid. The mixture of esters obtained from skin cond. agent-emol. the reaction of 2-octyldodecanol and the fatty-acids derived from coconut acid. Octyldodecyl Erucate the ester of octyldodecanol and erucic acid. The ester obtained from the reaction of skin cond. agent-oc. 88103-59-7 2-octyldodecanol with erucic acid. Octyldodecyl Hydroxystearate the ester of Octyldodecanol and 12-hydroxystearic acid. The ester obtained from the skin cond. agent-oc. 308122-33-0 reaction of 2-octyldodecanol and 12-hydroxystearic acid. Octyldodecyl Isostearate the ester of Octyldodecanol and isostearic acid. The mixture of esters obtained from skin cond. agent-oc. 93803-87-3 the reaction of 2-octyldodecanol with isostearic acid. Octyldodecyl Meadowfoamate the ester of Octyldodecanol and the fatty acids derived from Limnanthes Alba skin cond. agent-oc. (Meadowfoam) Seed Oil. The mixture of esters obtained from the reaction of 2-octyldodecanol with the fatty acids derived from Limnanthes Alba (Meadowfoam) Seed Oil. Octyldodecyl Myristate the ester of octyldodecanol and myristic acid. The ester obtained from the reaction skin cond. agent-oc. 22766-83-2; 83826-43-1 of 2-octyldodecanol with myristic acid. Octyldodecyl Neodecanoate the ester of Octyldodecanol and neodecanoic acid. The ester obtained from the skin cond. agent-emol. 1004272-41-6 reaction of 2-octyldodecanol with neodecanoic acid. Octyldodecyl Neopentanoate the ester of Octyldodecanol and neopentanoic acid. The ester obtained from the skin cond. agent-emol. 158567-66-9 reaction of 2-octyldodecanol with neopentanoic acid. Octyldodecyl Octyldodecanoate the ester of Octyldecanol and octyldodecanoic acid. The ester obtained from the skin cond. agent-oc. reaction of 2-octyldecanol with 2-octyldodecanoic acid.

48

Table 5. Definitions and functions Ingredient/CAS No. Definition37 (italicized text generated by CIR) Function37 Octyldodecyl Oleate the ester of Octyldodecanol and oleic acid. The ester obtained from the reaction of skin cond. agent-oc. 22801-45-2 2-octyldodecanol with oleic acid. Octyldodecyl Olivate the ester of Octyldodecanol and the fatty acids derived from Olea Europaea (Olive) skin cond. agent-emol.; skin cond. 22801-45-2 Oil. The ester obtained from the reaction of 2-octyldodecanol with the fatty acids agent-oc.; binder; film former; hair derived from Olea Europaea (Olive) Oil. cond. agent; slip modifier Octyldodecyl Ricinoleate the ester of octyldodecanol and ricinoleic acid. The ester obtained from the reaction hair cond. agent; 79490-62-3; 125093-27-8 of 2-octyldodecanol with ricinoleic acid. Octyldodecyl Safflowerate the ester of Octyldodecanol and the fatty acids derived from Carthamus Tinctorius skin cond. agent-emol. (Safflower) Oil. The ester obtained from the reaction of 2-octyldodecanol with the fatty acids derived from Carthamus Tinctorius (Safflower) Oil. Octyldodecyl Stearate the ester of octyldodecanol and stearic acid. The ester obtained from the reaction of skin cond. agent-oc. 22766-82-1 2-octyldodecanol with stearic acid. Oleyl Arachidate the ester of oleyl alcohol and Arachidic Acid. The ester obtained from the reaction skin cond. agent-oc. 22393-96-0; 156952-79-3 of oleyl alcohol with arachidic acid. Oleyl Erucate the ester of Oleyl Alcohol and erucic acid. The ester obtained from the reaction of skin cond. agent-oc. 17673-56-2; 143485-69-2 oleyl alcohol with erucic acid. Oleyl Linoleate the ester of Oleyl Alcohol and Linoleic Acid. The ester obtained from the reaction of skin cond. agent-oc.; hair cond. 17673-59-5 oleyl alcohol with linoleic acid. agent Oleyl Myristate the ester of oleyl alcohol and myristic acid. The ester obtained from the reaction of skin cond. agent-oc.; hair cond. 22393-93-7 oleyl alcohol with myristic acid. agent Oleyl Oleate the ester of Oleyl Alcohol and oleic acid. The ester obtained from the reaction of skin cond. agent-emol.; skin cond. 3687-45-4; 17363-94-9 oleyl alcohol with oleic acid. agent-emol. Oleyl Stearate the ester of oleyl alcohol and stearic acid. The ester obtained from the reaction of skin cond. agent-oc.; hair cond. 33057-39-5; 17673-50-6 oleyl alcohol with stearic acid. agent Propylheptyl Caprylate the organic compound that conforms to the formula. The ester obtained from the skin cond. agent-emol. 868839-23-0 reaction of 2-propylheptanol with caprylic acid. Stearyl Beeswax the ester of Stearyl Alcohol and Beeswax Acid. The mixture of esters obtained from skin cond. agent-oc. 42233-11-4 the reaction of stearyl alcohol with a mixture of straight-chain fatty acids, containing 24 to 36 carbons in alkyl chain length (beeswax acid). Stearyl Behenate the ester of stearyl alcohol and behenic acid. The ester obtained from the reaction of skin cond. agent-oc. 24271-12-3 stearyl alcohol with behenic acid. Stearyl Caprylate the ester of stearyl alcohol and caprylic acid. The ester obtained from the reaction of skin cond. agent-oc. 18312-31-7 stearyl alcohol with caprylic acid. Stearyl Erucate the ester of stearyl alcohol and erucic acid. The ester obtained from the reaction of visc. incr. agent-nonaq. 86601-84-5; 96810-34-3 stearyl alcohol with erucic acid. Stearyl Heptanoate the ester of stearyl alcohol and heptanoic acid. The ester obtained from the reaction skin cond. agent-oc. 66009-41-4 of stearyl alcohol with heptanoic acid. Stearyl Linoleate the ester of stearyl alcohol and linoleic acid that conforms to the formula. The ester skin cond. agent-oc.; visc. incr. 17673-53-9 obtained from the reaction of stearyl alcohol with linoleic acid. agent-nonaq. Stearyl Olivate the ester of stearyl alcohol and the fatty acids derived from Olea Europaea (Olive) skin cond. agent-emol.; surf- Oil. The ester obtained from the reaction of stearyl alcohol with the fatty acids emulsifying agent derived from Olea Europaea (Olive) Oil. Stearyl Palmitate the ester of stearyl alcohol and palmitic acid. The ester obtained from the reaction of skin cond. agent-misc.; hair cond. 2598-99-4 stearyl alcohol with palmitic acid. agent; binder; emul. stab; humec- tant; film former; opacifying agent Stearyl Stearate the ester of stearyl alcohol and stearic acid. The ester obtained from the reaction of skin cond. agent-oc.; visc. incr. 2778-96-3 stearyl alcohol with stearic acid. agent-nonaq. Tetradecyleicosyl Stearate the ester of Myristyleicosanol and stearic acid. The ester obtained from the reaction skin cond. agent-oc. of myristyleicosanol with stearic acid. Tetradecyloctadecyl Behenate the ester of Tetradecyloctadecanol and Behenic Acid. The ester obtained from the skin cond. agent-oc.; binder; emul. reaction of tetradecyloctadecanol with behenic acid. stab; film former; opacifying agent Tetradecyloctadecyl the organic compound that conforms to the formula. The ester obtained from the skin cond. agent-emol. Hexyldecanoate reaction of 2-tetradecyloctyldecanol with 2-hexyldecanoic acid. 93982-00-4 Tetradecyloctadecyl Myristate the ester of tetradecyloctadecanol and myristic acid. The ester obtained from the skin cond. agent-oc.; binder; emul. reaction of 2-tetradecyloctyldecanol with myristic acid. stab; film former; opacifying agent Tetradecyloctadecyl Stearate the ester of Tetradecyloctadecanol and stearic acid. The ester obtained from the skin cond. agent-oc.; binder; emul. reaction of 2-tetradecyloctadecanol with stearic acid. stab; film former; opacifying agent Tetradecylpropionates an isomeric mixture of esters consisting chiefly of 2-tetradecylproprionate, 3- skin cond. agent-emol.; solvent tetradecylproprionate, and 4-tetradecylproprionate. The mixture of esters obtained from the reaction of a mixture of 2-, 3-, and 4-tetradecanols with propionic acid. Tridecyl Behenate the ester of Tridecyl Alcohol and Behenic Acid. The ester obtained from the skin cond. agent-oc. 42233-08-9 reaction of tridecyl alcohol with behenic acid. Tridecyl Cocoate the ester of tridecyl alcohol and coconut acid. The mixture of esters obtained from skin cond. agent-oc. the reaction of tridecyl alcohol with the fatty acids derived from coconut acid. Tridecyl Erucate the ester of Tridecyl Alcohol and erucic acid. The ester obtained from the reaction of skin cond. agent-oc. 131154-74-0; 221048-36-8 tridecyl alcohol with erucic acid. Tridecyl Isononanoate the ester of Tridecyl Alcohol and isononanoic acid that conforms to the formula. The skin cond. agent-emol. 125804-18-4 ester of tridecyl alcohol and branched-chain nonanoic acids. Tridecyl Laurate the ester of tridecyl alcohol and lauric acid that conforms to the formula. The ester skin cond. agent-oc. 36665-67-5 obtained from the reaction of tridecyl alcohol with lauric acid.

49

Table 5. Definitions and functions Ingredient/CAS No. Definition37 (italicized text generated by CIR) Function37 Tridecyl Myristate the ester of tridecyl alcohol and myristic acid. The ester obtained from the reaction skin cond. agent-oc. 36617-27-3 of tridecyl alcohol with myristic acid. Tridecyl Neopentanoate the ester of Tridecyl Alcohol and neopentanoic acid. The ester obtained from the skin cond. agent-emol. 106436-39-9; 105859-93-6 reaction of tridecyl alcohol with neopentanoic acid. Tridecyl Stearate the ester of Tridecyl Alcohol and stearic acid. The ester obtained from the reaction skin cond. agent-emol. 31556-45-3 of tridecyl alcohol with stearic acid. Abbreviations: cond. – conditioning; disp. – dispersing; emol. – emollient; emul. – emulsion; incr. – increasing; ingr. – ingredient; misc. – miscellaneous; nonaq. – non-aqueous; nonsurf – non-surfactant; oc. – occlusive; solub. – solubilizing; stab. – stabilizer; surf. – surfactant; visc. – viscosity

Table 6. Methods of Manufacture Ingredient Method of Manufacture Reference 13 Arachidyl Propionate manufactured as a mixture of the esters of the C18 – C28 fatty alcohols, of which C20 fatty alcohol ester is the major constituent Butyl Oleate reaction of butanol and oleic acid in the presence of dihydrogen phosphate 68 prepared from n-butanol and oleic acid by heating, with sulfuric acid as a catalyst 69,70 esterification of oleic acid with butyl alcohol in n-hexane in the presence of the macroporous sulfonic resin K2411 71 synthesized with Candida antarctica lipase catalyst or using a sodium alcoholate catalyst 35 esterification of oleic acid with butanol in the presence of p-toluene sulfonic acid 72 lipase-catalyzed oleic acid esterification by n-butyl alcohol in almost non-aqueous media without an organic solvent 73 Butyl Myristate derived from the esterification of myristic acid and butyl alcohol in the presence of an acid catalyst 14 Butyl Stearate the esterification of stearic acid with butyl alcohol; the reaction products are refined either by catalyst neutralization, 11 vacuum distillation, or various decolorization-deodorization techniques to remove traces of alcohol Cetyl Behenate esterification of behenic acid with cetyl alcohol using n-butyl benzene as the solvent and tetra n-butyl titanate as the 74 catalyst Cetyl Oleate cetyl alcohol and oleic acid were dissolved in benzene and heated, using sulfuric acid as a catalyst; the mixture was then 47 washed, the benzene filtered and removed by vacuum distillation, and the ester separated twice by distillation esterification of oleic acid with cetyl alcohol in n-hexane in the presence of p-toluene sulfonic acid 71 lipase-catalyzed oleic acid esterification by cetyl alcohol in almost non-aqueous media without an organic solvent 73 Cetyl Stearate the esterification of stearic acid with cetyl alcohol; the reaction products are refined either by catalyst neutralization, 11 vacuum distillation, or various decolorization-deodorization techniques to remove traces of alcohol Ethylhexyl Laurate co-produced by the lipase-catalyzed acylation of racemic alcohol and vinyl laurate in the production of (R)-2-ethylhexanol 75 Ethylhexyl Oleate synthesized with Candida antarctica lipase catalyst or using a sodium alcoholate catalyst 35 Ethylhexyl Stearate the esterification of stearic acid with octyl alcohol; the reaction products are refined either by catalyst neutralization, 11 vacuum distillation, or various decolorization-deodorization techniques to remove traces of alcohol Isobutyl Stearate the esterification of stearic acid with isobutyl alcohol; the reaction products are refined either by catalyst neutralization, 11 vacuum distillation, or various decolorization-deodorization techniques to remove traces of alcohol Isocetyl Myristate the esterification of isocetyl alcohol and myristic acid 16 Isocetyl Stearate the esterification of stearic acid with isocetyl alcohol; the reaction products are refined either by catalyst neutralization, 11 vacuum distillation, or various decolorization-deodorization techniques to remove traces of alcohol can be made by heating with or without acid catalyst Isopropyl Arachidate arachidic acid was treated with isopropyl alcohol in large molar excess, p-toluene sulfonic acid was the catalyst 76 Isopropyl Laurate lauric acid was treated with isopropyl alcohol in large molar excess, p-toluene sulfonic acid was the catalyst 76 Isopropyl Myristate commercially produced by distillation, which is preceded by the esterification of myristic acid and isopropanol, in the 10 presence of an acid catalyst Isopropyl Oleate esterification of oleic acid with isopropyl alcohol in n-hexane in the presence of K2411 71 synthesized with Candida antarctica lipase catalyst or using a sodium alcoholate catalyst 35 Isopropyl Stearate the esterification of stearic acid with isopropyl alcohol; the reaction products are refined either by catalyst neutralization, 11 vacuum distillation, or various decolorization-deodorization techniques to remove traces of alcohol Isostearyl Neopentanoate prepared by esterifying isostearyl alcohol with neopentanoic acid in the presence of a catalyst 12 Lauryl Behenate esterification of behenic acid with lauryl alcohol using n-butyl benzene as the solvent and tetra n-butyl titanate as the 74 catalyst Lauryl Oleate esterification of oleic acid with lauryl alcohol in n-hexane in the presence of p-toluene sulfonic acid 71 synthesized with Candida antarctica lipase catalyst or using a sodium alcoholate catalyst Lauryl Palmitate lipase-catalyzed esterification of palmitic acid and lauryl alcohol using Novozym 435 as the biocatalyst 77 Myristyl Laurate the fatty acid chloride was reacted with myristic acid in the presence of pyridine, using diethyl ether as the solvent 78 Myristyl Myristate produced by the esterification of myristic acid and myristyl alcohol in the presence of an acid catalyst 10 Myristyl Stearate the esterification of stearic acid with myristyl alcohol; the reaction products are refined either by catalyst neutralization, 11 vacuum distillation, or various decolorization-deodorization techniques to remove traces of alcohol Octyldodecyl Myristate the esterification of myristic acid with 2-octyl dodecanol, manufactured from vegetable sources 16 Oleyl Arachidate the fatty acid chloride was reacted with oleic acid in the presence of pyridine, using diethyl ether as the solvent 78 Oleyl Oleate the fatty acid chloride was reacted with oleic acid in the presence of pyridine, using diethyl ether as the solvent 78 lipase-catalyzed oleic acid esterification by oleyl alcohol in almost non-aqueous media without an organic solvent 73 synthesized with Candida antarctica lipase catalyst or using a sodium alcoholate catalyst 35 Oleyl Stearate the fatty acid chloride was reacted with oleic acid in the presence of pyridine, using diethyl ether as the solvent 78

50

Table 7. Chemical and physical properties Property Description Reference Arachidyl Behenate molecular weight 621.12 79 boiling point 648.7°C (760 Torr) (calculated) 79 density 0.856 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 20.146 (25°C) (calculated) 79 Arachidyl Erucate molecular weight 619.10 79 boiling point 608.3°C (760 Torr) (calculated) 79 density 0.898 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 16.353 (25°C) (calculated) 79 Arachidyl Propionate characteristics soft, waxy, amber-colored solid with a slight characteristic odor 13 melting point 36-38°C 13 boiling point 224°C 13 specific gravity 0.83 13 solubility soluble in mineral oil 13 insoluble in water Batyl Stearate molecular weight 611.03 79 boiling point 656.9°C (760 Torr) (calculated) 79 density 0.856 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 20.146 (25°C) (calculated) 79 pKa 14.08 (most acidic temperature: 25°C) (calculated) 79 Behenyl Behenate molecular weight 649.18 80 Behenyl Erucate molecular weight 647.15 79 boiling point 669.1°C (760 Torr) (calculated) 79 density 0.860 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 20.755 (25°C) (calculated) 79 Butyl Myristate form colorless oily liquid 14 boiling point 167-197°C (5 mm Hg) 14 specific gravity 0.850 – 0.858 (25°C) 14 solubility soluble in acetone, castor oil, chloroform, methanol, mineral oil, and toluene 14 insoluble in water Butyl Oleate appearance and form mobile, yellow, oily liquid molecular weight 338.57 68 melting point -31.7°C 35 -35.5°C 72 boiling point 235-45 °C 68 density 0.870 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 9.547 (25°C) (calculated) 79 Butyl Stearate characteristics stable, colorless, oily liquid 11 molecular weight 340.57 11 melting point 16-20.5°C 11 boiling point 212-216°C 11 specific gravity 0.851-0.861 (20°/20°C) 11 refractive index 1.441 (25°C) 11 saponification value 146-177 11 solubility soluble in acetone, chloroform, ether, alcohol, ketones, , aromatic and aliphatic hydrocarbons, fats, 11 waxes, mineral oils, and many plasticizers insoluble in water Caprylyl Butyrate molecular weight 200.32 79,80 melting point -55.6°C 81 boiling point 244.1°C 81 water solubility 5.81 mg/l (25°C) (estimated) 81 density 0.870 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 4.861 (25°C) (calculated) 79 Caprylyl Caprylate molecular weight 256.42 79,80 melting point -18.1°C 81 boiling point 306.8°C 81 water solubility 0.112 mg/l (25°C) (estimated) 81 density 0.865 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 6.899 (25°C) (calculated) 79 Cetearyl Isononanoate form yellowish liquid 19 melting point <15°C 19 refractive index 1.445 – 1.450 19 density 0.854 – 8.858 g/ml 19 51

Table 7. Chemical and physical properties Property Description Reference saponification value 140-146 19 solubility insoluble in water 19 Cetyl Behenate molecular weight 565.01 79 melting point 65°C 74 boiling point 569.4°C (760 Torr) (calculated) 79 density 0.857 g/cm3 (20°C; 760 Torr) (calculated) 79 specific gravity 0.8178 – 0.804 (70 - 100°C, respectively) 74 refractive index 1.441 – 1.433 (70 - 90°C, respectively) 74 log P 18.108 (25°C) (calculated) 79 Cetyl Caprylate form liquid 53 molecular weight 368.64 79,80 boiling point 414.2°C (760 Torr) (calculated) 79 density 0.860 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 10.975 (25°C) (calculated) 79 Cetyl Esters characteristics white to off-white, somewhat translucent solid with a crystalline structure and a faint odor 82 melting range 43-47°C 82 specific gravity 0.820-0.840 (50°C) 82 saponification value 109 - 120 82 solubility soluble in boiling alcohol, ether, chloroform, and fixed oils 82 insoluble in water and cold alcohol 82 composition mixture consisting of esters of primarily saturated fatty alcohols (C14 to C18) and saturated fatty acids (C14 to C18) Cetyl Isononanoate molecular weight 382.66 19 log P 0.28 (calculated) 19 Cetyl Laurate molecular weight 424.74 79 melting point 40-41°C 83 boiling point 462.2°C (760 Torr) (calculated) 79 density 0.860 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 113.013 (25°C) (calculated) 79 Cetyl Myristoleate molecular weight 450.78 79 boiling point 519.6°C (calculated) 79 log P 14.005 (25°C) (calculated) 79 Cetyl Oleate molecular weight 506.89 80 melting point 25.5°C 84 saponification value 110.7 47 Cetyl Palmitate molecular weight 481 9 characteristics white, crystalline, wax-like substance 9 melting point 46 - 54°C 9 specific gravity 0.832 (25°C) 9 9 refractive index 1.4398 (nD70) solubility soluble in alcohol and ether 9 insoluble in water C32-36 Isoalkyl Stearate molecular weight 761.38 80 Decyl Cocoate characteristics almost odorless light yellow liquid 17 specific gravity 0.85 g/cm3 (25°C) 17 saponification value 155 -* 170 17 Decyl Laurate molecular weight 340.58 80 boiling point 388.9°C (760 Torr) (calculated) 79 log P 9.956 (25°C) (calculated) 79 Decyl Oleate characteristics light yellow liquid 36 molecular weight 422 36 specific gravity 0.855 – 0.865 36 saponification value 103-142 36 solubility soluble in alcohol 36 insoluble in water Decyl Palmitate molecular weight 396.69 79,80 melting point 30°C 85 boiling point 438.7°C (760 Torr) (calculated) 79 density 0.860 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 11.994 (25°C) (calculated) 79

52

Table 7. Chemical and physical properties Property Description Reference Ethylhexyl Hydroxystearate characteristics clear to slightly opalescent, yellow, oily liquid with a slight fatty odor 82 boiling point 490.6°C (760 Torr) (calculated) 79 specific gravity 0.889-0.895 (25°/25°C) 82 saponification value 140-160 82 solubility soluble in ethyl alcohol and corn oil 82 insoluble in water and propylene glycol log P 9.776 (25°C) (calculated) 79 Ethylhexyl Isononanoate molecular weight 270.45 19 log P 5.91 (calculated) 19 Ethylhexyl Isopalmitate form liquid 53 Ethylhexyl Laurate molecular weight 312.53 79,80 melting point -30°C 57 boiling point >250°C (1013 hPa) 57 124-126°C (0.1 mm Hg) 75 water solubility 1 mg/l (20°C) 57 density 0.86 g/cm3 (20°C) 57 log P 8.781 (25°C) (calculated) 79 Ethylhexyl Oleate molecular weight 394.67 79 melting point -2.9°C 35 boiling point 465.8°C (760 Torr) (calculated) 79 density 0.867 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 11.429 (25°C) (calculated) 79 Ethylhexyl Palmitate molecular weight 388 9 characteristics clear, colorless, practically odorless liquid 9 specific gravity 0.850 – 0.865 (25°C) 9 refractive index 1.445 – 1.4465 (25°C) 9 solubility soluble in acetone, castor oil, corn oil, chloroform, ethanol, and mineral oil 9 insoluble in water, glycerin, and propylene glycol Ethylhexyl Pelargonate molecular weight 270.45 19 density 0.864 ± 0.06 g/cm3 (20°C) 19 log P 7.432 (calculated) 19 Ethylhexyl Stearate molecular weight 396 11 Erucyl Erucate molecular weight 645.14 79 boiling point 668.1°C (760 Torr) (calculated) 79 density 0.865 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 20.346 (25°C) (calculated) 79 Erucyl Oleate molecular weight 589.03 79 boiling point 631.3 79 density 0.866 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 18.308 (25°C) (calculated) 79 Heptyl Undecylenate molecular weight 282.46 79,80 boiling point 351.0°C (760 Torr) (calculated) 79 density 0.871 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 7.510 (25°C) (calculated) 79

Heptylundecyl Hydroxystearate molecular weight 552.96 79 boiling point 607.3°C (760 Torr) (calculated) 79 density 0.885 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 14.870 (25°C) (calculated) 79 pKa 15.40 (most acidic temp: 25°C) 79 Hexyldecyl Laurate molecular weight 424.74 80 Hexyldecyl Oleate molecular weight 506.89 79,80 boiling point 563.6°C (760 Torr) (calculated) 79 density 0.863 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 15.505 (25°C) (calculated) 79 Hexyldecyl Palmitate molecular weight 480.85 80

53

Table 7. Chemical and physical properties Property Description Reference Hexyl Laurate molecular weight 284.48 79,80 melting point -3.4°C 86 boiling point 130°C 86 density 0.864 g/cm3 (20°C; 760 Torr) (calculated) 79 refractive index 1.4382 86 log P 7.918 (25°C) (calculated) 79 Hydroxyoctacosanyl Hydroxystearate molecular weight 709.22 79,80 boiling point 311.8°C (760 Torr) (calculated) 79 density 0.864 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 7.253 (25°C) (calculated) 79 Isoamyl Laurate molecular weight 270.45 79,80 boiling point 631.3 79 density 0.866 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 18.308 (25°C) (calculated) 79 Isobutyl Palmitate molecular weight 312.53 79,80 boiling point 354.6°C (760 Torr) (calculated) 79 density 0.862 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 8.781 (25°C) (calculated) 79 Isobutyl Pelargonate molecular weight 214.34 19 density 0.867 ± 0.06 g/cm3 (20°C) 19 log P 5.307 (calculated) 19 Isobutyl Stearate characteristics a paraffinlike crystal substance a low temperature; a liquid at room temperature 11 molecular weight 340.57 11 melting point 20°C 11 saponification value 170-180 11 Isocetyl Myristate characteristics oily liquid with practically no odor 16 density 0.862 16 solubility soluble in most organic solvents 16 insoluble in water Isocetyl Isostearate form liquid 53 molecular weight 508.9 80 Isocetyl Palmitate form liquid 53 Isocetyl Stearate characteristics an oily, colorless or yellow liquid with practically no odor 11 molecular weight 508 11 specific gravity 0.8520-00.858 (25°/25°C) 11 refractive index 1.451-1.453 (25°C) 11 saponification value 110-118 11 solubility soluble in ethanol, isopropanol, mineral oil, castor oil, acetone, and ethyl acetate 11 insoluble in water, glycerin, and propylene glycol Isodecyl Isononanoate molecular weight 298.5 19 refractive index 1.437 – 1.439 (25°C) 19 specific gravity 0.852 – 0.858 (25°/25°C) 19 saponification value 175 – 192 19 log P 6.68 (calculated) 19 Isodecyl Laurate form colorless or pale yellow liquid 58 molecular weight 340.58 79 boiling point 374.2°C (760 Torr) (calculated) 79 density 0.860 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 9.644 (25°C) (calculated) 79 Isodecyl Neopentanoate molecular weight 242.40 80 Isodecyl Oleate molecular weight 422 36 saponification value 130-145 36 Isodecyl Palmitate molecular weight 396.69 79,80 boiling point 425.2°C (760 Torr) (calculated) 79 density 0.858 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 11.682 (25°C) (calculated) 79 Isodecyl Stearate molecular weight 424.74 80

54

Table 7. Chemical and physical properties Property Description Reference Isohexyl Caprate molecular weight 256.42 79 boiling point 296.8°C (760 Torr) (calculated) 79 density 0.864 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 6.743 (25°C) (calculated) 79 Isohexyl Laurate characteristics pale yellow liquid with a coconut-like odor 82 molecular weight 284.48 79 boiling point 326.5°C (760 Torr) (calculated) 79 refractive index 1.439 - 1.442 (20°C) 82 specific gravity 0.843 -0.853 (25°/25°C) 82 saponification value 130 - 145 82 solubility soluble in most organic solvents 82 insoluble in water free fatty acid content 0.1% (max.) (as lauric acid) 82 log P 7.762 (25°C) (calculated) 79 Isohexyl Neopentanoate molecular weight 186.29 79 boiling point 193.2°C (760 Torr) (calculated) 79 density 0.870 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 3.941 (25°C) (calculated) 79 Isohexyl Palmitate characteristics light yellow liquid with a fatty-type odor 82 molecular weight 340.58 79 boiling point 381.5°C (760 Torr) (calculated) 79 refractive index 1.4433 - 1.4443 (20°C) 82 specific gravity 0.850 -0.860 (25°/25°C) 82 saponification value 165-171 82 solubility soluble in alcohol and mineral oil 82 insoluble in water and lower glycols and glycerin log P 9.800 (25°C) (calculated) 79 Isononyl Isononanoate molecular weight 284.48 19 refractive index 1.430 – 1.436 (25°C) 19 specific gravity 0.849 – 0.855 (25°/25°C) 19 saponification value 192 - 202 19 log P 6.27 (calculated) 19 Isopropyl Arachidate form white crystal 76 molecular weight 354.61 79 melting point 53-55°C 76 boiling point 394.4°C (760 Torr) (calculated) 79 density 0.860 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 10.310 (25°C) (calculated) 79 Isopropyl Behenate molecular weight 382.66 79 boiling point 419.6°C (760 Torr) (calculated) 79 density 0.859 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 11.329 (25°C) (calculated) 79 Isopropyl Isostearate form liquid 2 specific gravity 0.853 – 0.859 (25°C) 2 solubility soluble in acetone, ethyl acetate, isopropyl alcohol, and mineral oil 2 Isopropyl Laurate form yellow oil 76 molecular weight 242.40 79 boiling point 196°C 81 specific gravity 0.851-0.857 87 refractive index 1.427-1.433 (20°C) 87 solubility insoluble in water 87 solubility in 95% ethanol, 1 ml in 1 ml log P 6.234 (25°C) (calculated) 79 Isopropyl Linoleate molecular weight 322.53 79 boiling point 399.0°C (760 Torr) (calculated) 79 density 0.880 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 8.478 (25°C) (calculated) 79 Isopropyl Myristate characteristics colorless, almost odorless liquid with a bland taste 10 boiling point 192.6°C (20 mm Hg) 10 specific gravity 0.847 – 0.853 (25°C) 10 refractive index 1.432 – 1.430 (25°C) 10 solubility soluble in acetone, castor oil, chloroform, cottonseed oil, ethanol, ethyl acetate, mineral oil, and toluene 10 insoluble in water, glycerol, sorbitan, and propylene glycol 55

Table 7. Chemical and physical properties Property Description Reference Isopropyl Oleate molecular weight 324.54 80 melting point -33.4°C 35 boiling point 369.8°C (760 Torr) (calculated) 79 density 0.870 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 8.881 (25°C) (calculated) 79 Isopropyl Palmitate molecular weight 318 9 characteristics colorless, almost odorless, mobile liquid mixture of isopropyl esters consisting of a minimum of 60% isopropyl 9 palmitate melting point 11°C 9 specific gravity 0.850 – 0.855 (25°C) 9 refractive index 1.4355 – 1.4375 (25°C) 9 solubility soluble in acetone, castor oil, chloroform, cottonseed oil, ethyl acetate, ethanol, and mineral oil 9 insoluble in water, glycerin, and propylene glycol Isopropyl Stearate form liquid at room temperature 11 molecular weight 326 11 Isopropyl Sorbate molecular weight 154.21 79 boiling point 200.0°C (760 Torr) (calculated) 79 density 0.916 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 2.770 (25°C) (calculated) 79 Isostearyl Hydroxystearate molecular weight 552.96 79 boiling point 607.3°C (760 Torr) (calculated) 79 density 0.885 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 14.870 (25°C) (calculated) 79 Isostearyl Isononanoate molecular weight 410.72 19 log P 10.02 calculated) 19 Isostearyl Isostearate molecular weight 536.96 80 log P 17.399 (calculated) 52 Isostearyl Neopentanoate form clear, slightly yellow liquid 12 molecular weight 348-390 12 refractive index 1.4485 – 1.4515 (25°C) 12 specific gravity 0.858 – 0.870 (25°C) 12 saponification value 144 – 161 12 solubility soluble in mineral oil, 95% ethanol, propylene glycol , isopropyl myristate, oleyl alcohol, peanut oil 12 insoluble in water, 80% ethanol, Isotridecyl Isononanoate molecular weight 340.58 19 refractive index 1.433 – 1.445 (25°C) 19 specific gravity 0.859 – 0.861 (25°/25°C) 19 saponification value 155 - 162 19 log P 7.94 (calculated) 19 Isotridecyl Laurate molecular weight 382.66 79 boiling point 419.6°C (760 Torr) (calculated) 79 density 0.859 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 11.329 (25°C) (calculated) 79 Isotridecyl Stearate molecular weight 466.82 80 Lauryl Behenate molecular weight 508.90 79 melting point 53°C 74 boiling point 528.4°C (760 Torr) (calculated) 79 specific gravity 0.8295 – 0.8137 (60 - 90°C, respectively) 74 refractive index 1.443 – 1.433 (60 - 80°C, respectively) 74 log P 16.070 (25°C) (calculated) 79 Lauryl Laurate molecular weight 368.64 79 melting point 27°C 88 boiling point 226°C 88 density 0.860 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 10.975 (25°C) (calculated) 79 Lauryl Oleate molecular weight 485.75 79 melting point 14.5°C 89 18.4°C 35 boiling point 519.6°C (760 Torr) (calculated) 79

56

Table 7. Chemical and physical properties Property Description Reference density 0.865g/cm3 (20°C; 760 Torr) (calculated) 79 log P 13.623 (25°C) (calculated) 79 Lauryl Palmitate molecular weight 424.74 79 boiling point 462.2°C (760 Torr) (calculated) 79 density 0.859 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 13.013 (25°C) (calculated) 79 Lauryl Stearate molecular weight 452.08 79 boiling point 484.9°C (760 Torr) (calculated) 79 density 0.858 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 14.032 (25°C) (calculated) 79 Myristyl Laurate molecular weight 396.69 79 boiling point 438.7°C (760 Torr) (calculated) 79 density 0.860 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 11.994 (25°C) (calculated) 79 Myristyl Myristate melting point 37-39°C 10 saponification value 119 - 129 10 Myristyl Neopentanoate molecular weight 298.50 79 boiling point 332.3°C (760 Torr) (calculated) 79 density 0.863 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 8.173 (25°C) (calculated) 79 Myristyl Laurate melting point 40-40.4°C 78 Myristyl Stearate molecular weight 480.85 79 form waxy solid at room temperature 11 Octyldodecyl Behenate molecular weight 621.12 79 boiling point 603.0°C (760 Torr) (calculated) 79 density 0.855 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 19.990 (25°C) (calculated) 79 Octyldodecyl Erucate molecular weight 619.10 79 boiling point 646.0°C (760 Torr) (calculated) 79 density 0.860 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 19.581 (25°C) (calculated) 79 Octyldodecyl Myristate characteristics colorless odorless liquid 16 saponification value 105 - 111 16 Octyldodecyl Neopentanoate molecular weight 382.66 79 boiling point 405.6°C (760 Torr) (calculated) 79 density 0.859 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 11.074 (25°C) (calculated) 79 Octyldodecyl Oleate molecular weight 562.99 79 boiling point 608.2°C (760 Torr) (calculated) 79 density 0.861 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 17.543 (25°C) (calculated) 79 Octyldodecyl Stearate molecular weight 565.01 79 boiling point 563.8°C (760 Torr) (calculated) 79 density 0.856 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 17.952 (25°C) (calculated) 79 Oleyl Arachidate molecular weight 562.99 79 melting point 39.5-40°C 78 boiling point 617.5°C (760 Torr) (calculated) 79 density 0.862 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 17.699 (25°C) (calculated) 79 Oleyl Erucate molecular weight 589.03 79 boiling point 637.7°C (760 Torr) (calculated) 79 density 0.866 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 18.308 (25°C) (calculated) 79 Oleyl Linoleate molecular weight 530.91 79 boiling point 595.5°C (760 Torr) (calculated) 79 density 0.874 g/cm3 (20°C; 760 Torr) (calculated) 79

57

Table 7. Chemical and physical properties Property Description Reference log P 15.867 (25°C) (calculated) 79 Oleyl Oleate molecular weight 532.92 79 melting point -4.0 to -3.5°C 78 -1.5°C 35 boiling point 596.5°C (760 Torr) (calculated) 79 density 0.868 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 16.270 (25°C) (calculated) 79 Oleyl Stearate molecular weight 534.94 79 melting point 34.0-34.5°C 78 boiling point 595.8°C (760 Torr) (calculated) 79 density 0.862 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 16.680 (25°C) (calculated) 79 Propylheptyl Caprylate molecular weight 284.48 79 purity >80% 56 melting point -38.9°C 56 boiling point 319.0°C (101.3 kPa) 56 water solubility <0.01 mg/l (20°C) 56 density 0.863 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 7.963 (25°C) (calculated) 79 Stearyl Erucate molecular weight 591.05 79 boiling point 627.8°C (760 Torr) (calculated) 79 density 0.861 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 18.718 (25°C) (calculated) 79 Stearyl Linoleate molecular weight 532.92 79 boiling point 590.8°C (760 Torr) (calculated) 79 density 0.868 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 16.276 (25°C) (calculated) 79 Tetradecyloctadecyl Hexyldecanoate molecular weight 705.27 79 boiling point 653.7°C (760 Torr) (calculated) 79 density 0.854 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 22.891 (25°C) (calculated) 79 Tridecyl Behenate molecular weight 522.93 79 boiling point 538.8°C (760 Torr) (calculated) 79 density 0.857 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 16.579 (25°C) (calculated) 79 Tridecyl Erucate molecular weight 520.91 79 boiling point 573.1°C (760 Torr) (calculated) 79 density 0.863 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 16.170 (25°C) (calculated) 79 Tridecyl Laurate molecular weight 382.66 79 boiling point 426.6°C (760 Torr) (calculated) 79 density 0.860 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 11.485 (25°C) (calculated) 79 Tridecyl Isononanoate molecular weight 340.58 19 log P 8.02 (calculated) 19 Tridecyl Stearate molecular weight 466.82 79 boiling point 496.0°C (760 Torr) (calculated) 79 density 0.858 g/cm3 (20°C; 760 Torr) (calculated) 79 log P 14.541 (25°C) (calculated) 79

58

Table 8. Frequency and concentration of use (historical and current) according to duration and type of exposure # of Uses Max Conc of Use (%) # of Uses Max Conc of Use (%) # of Uses Max Conc of Use (%) Arachidyl Behenate Arachidyl Propionate Behenyl Beeswax 201238 201239 201238 20057 201239 198713/ 201238 201239 20067 Totals* 20 0.3-4 48 47 0.0003-14.2 ≤10 1 0.4 Duration of Use Leave-On 20 0.3-4 39 44 0.002-14.2 ≤10 1 0.4 Rinse-Off NR NR 9 3 0.0003-14.1 0.002 NR NR Diluted for (Bath) Use NR NR NR NR NR NR NR NR Exposure Type Eye Area 5 3 3 NR 3-14 5 1 0.4 Incidental Ingestion 2 3-4 6 8 8-15 ≤10 NR NR Incidental Inhalation-Spray# NR NR NR 1b 14a ≤5b NR NR 0.0002 (spray) Incidental Inhalation-Powder NR NR NR NR 14 NR NR NR Dermal Contact 18 0.3-3 37 35 0.002-14.2 ≤5 NR 0.4 Deodorant (underarm) NR NR NR NR 14.1 (not a NR NR NR spray) Hair - Non-Coloring NR NR 5 4 0.0003- NR NR NR 0.003 Hair-Coloring NR NR NR NR NR NR NR NR Nail NR NR NR NR 0.05-0.09 0.04 NR NR Mucous Membrane 2 3-4 7 8 8-15 ≤10 NR NR Baby Products NR NR NR NR NR NR NR NR Behenyl Behenate Behenyl Erucate Behenyl Olivate 201238 201239 201238 201239 201238 201239 Totals* 5 0.4-5 9 0.5 NR 0.5 Duration of Use Leave-On 5 0.4-5 9 0.5 NR 0.5 Rinse Off NR NR NR NR NR NR Diluted for (Bath) Use NR NR NR NR NR NR Exposure Type Eye Area 2 0.6-5 NR NR NR NR Incidental Ingestion NR 4 9 0.5 NR NR Incidental Inhalation-Spray NR NR NR NR NR NR Incidental Inhalation-Powder NR NR NR NR NR NR Dermal Contact 5 0.4-2 NR NR NR 0.5 Deodorant (underarm) NR NR NR NR NR NR Hair - Non-Coloring NR NR NR NR NR NR Hair-Coloring NR NR NR NR NR NR Nail NR NR NR NR NR NR Mucous Membrane NR 4 9 0.5 NR NR Baby Products NR NR NR NR NR NR Butyl Avocadate Butyl Myristate Butyl Stearate 201238 201239 201238 200716 201239 200816 201238 20025 201239 198511/ 20035 Totals* 10 1 4 26 5 NR 10 78 0.0008-12 0.002-43 Duration of Use Leave-On 6 1 4 26 5 NR 10 73 0.002-12 0.002-25 Rinse-Off 4 NR NR NR NR NR NR 5 0.0008-2 0.001-10 Diluted for (Bath) Use NR NR NR NR NR NR NR NR NR 43 Exposure Type Eye Area NR NR NR NR NR NR 5 23 0.4-9 0.2-25 Incidental Ingestion NR NR NR 16 NR NR 2 34 0.1-12 0.02-25 Incidental Inhalation-Spray 1a NR NR NR NR NR NR NR 0.6a-5 NR Incidental Inhalation-Powder NR NR NR NR NR NR NR NR 0.5-2 NR Dermal Contact 6 1 4 10 NR NR 8 44 0.0008-9 0.02-43 Deodorant (underarm) NR NR NR NR NR NR NR 1 0.6 (not a >1-5b spray) Hair - Non-Coloring 4 NR NR NR 5 NR NR NR NR 0.01-10 Hair-Coloring NR NR NR NR NR NR NR NR NR NR Nail NR NR NR NR NR NR NR NR NR >0.1-5 Mucous Membrane NR NR NR 16 NR NR 2 39 0.1-12 0.1-43 Baby Products NR NR NR NR NR NR NR NR NR NR

59

Table 8. Frequency and concentration of use (historical and current) according to duration and type of exposure # of Uses Max Conc of Use (%) # of Uses Max Conc of Use (%) # of Uses Max Conc of Use (%) C20-40 Alkyl Stearate Caprylyl Caprylate Caprylyl Eicosenoate 201238 201239 201238 201239 201238 201239 Totals* 11 NR 11 NR 2 0.3 Duration of Use Leave-On 11 NR 11 NR 2 0.3 Rinse-Off NR NR NR NR NR NR Diluted for (Bath) Use NR NR NR NR NR NR Exposure Type Eye Area NR NR 1 NR NR NR Incidental Ingestion 8 NR NR NR NR NR Incidental Inhalation-Spray NR NR NR NR NR NR Incidental Inhalation-Powder NR NR NR NR NR 0.3 Dermal Contact NR NR 11 NR 2 0.3 Deodorant (underarm) NR NR NR NR NR NR Hair - Non-Coloring 3 NR NR NR NR NR Hair-Coloring NR NR NR NR NR NR Nail NR NR NR NR NR NR Mucous Membrane 8 NR NR NR NR NR Baby Products NR NR NR NR NR NR Cetearyl Behenate Cetearyl Candelillate Cetearyl Isononanoate 201238 201239 201238 201239 201238 200919 201239 200919 Totals* 3 7-15 2 6 162 123 0.2-40 0.05-50 Duration of Use Leave-On 3 7-15 2 6 140 108 0.2-40 0.05-50 Rinse-Off NR NR NR NR 22 15 1-4 2-3 Diluted for (Bath) Use NR NR NR NR NR NR NR NR Exposure Type Eye Area 1 NR NR NR 18 15 NR 0.05 Incidental Ingestion NR 7 1 6 1 1 5 NR Incidental Inhalation-Spray NR NR 1a NR 8a 7a,b 40 (spray) 27-50b 6 (pump spray) Incidental Inhalation-Powder NR NR NR NR 1 2 NR 0.05-11 Dermal Contact 3 14-15 1 NR 158 120 0.2-40 0.05-50 Deodorant (underarm) NR NR NR NR NR NR NR NR Hair - Non-Coloring NR NR NR NR 3 NR NR NR Hair-Coloring NR NR NR NR NR NR NR NR Nail NR NR NR NR 1 2 NR NR Mucous Membrane NR 7 1 6 3 3 5 NR Baby Products NR NR NR NR NR NR NR NR Cetearyl Nonanoate Cetearyl Olivate Cetearyl Stearate 201238 200919 201239 200919 201238 201240 201238 201240 Totals* NR NR NR 3 146 0.3-3 3 NR Duration of Use Leave-On NR NR NR 3 114 0.3-3 3 NR Rinse-Off NR NR NR NR 32 0.4-2 NR NR Diluted for (Bath) Use NR NR NR NR NR 2a NR NR Exposure Type Eye Area NR NR NR NR 14 1-3 NR NR Incidental Ingestion NR NR NR NR NR NR NR NR Incidental Inhalation-Spray NR NR NR NR 2a 2a NR NR Incidental Inhalation-Powder NR NR NR NR 1 NR NR NR Dermal Contact NR NR NR 3 141 0.3-3 3 NR Deodorant (underarm) NR NR NR NR 1b NR NR NR Hair - Non-Coloring NR NR NR NR 3 2 NR NR Hair-Coloring NR NR NR NR NR NR NR NR Nail NR NR NR NR NR NR NR NR Mucous Membrane NR NR NR NR 3 NR NR NR Baby Products NR NR NR NR 1 NR NR NR

60

Table 8. Frequency and concentration of use (historical and current) according to duration and type of exposure # of Uses Max Conc of Use (%) # of Uses Max Conc of Use (%) # of Uses Max Conc of Use (%) Cetyl Babassuate Cetyl Caprate Cetyl Caprylate 201238 201239 201238 201239 201238 201239 Totals* 2 NR NR 0.5 14 2-4 Duration of Use Leave-On 2 NR NR 0.5 12 2-4 Rinse-Off NR NR NR NR 2 NR Diluted for (Bath) Use NR NR NR NR NR NR Exposure Type Eye Area NR NR NR NR 1 NR Incidental Ingestion NR NR NR 0.5 NR NR Incidental Inhalation-Spray NR NR NR NR NR NR Incidental Inhalation-Powder NR NR NR NR 1 NR Dermal Contact 2 NR NR NR 12 2-4 Deodorant (underarm) NR NR NR NR NR NR Hair - Non-Coloring NR NR NR NR NR NR Hair-Coloring NR NR NR NR NR NR Nail NR NR NR NR NR NR Mucous Membrane NR NR NR 0.5 NR NR Baby Products NR NR NR NR 1 NR Cetyl Esters Cetyl Isononanoate Cetyl Laurate 201238 19951 201240 19951 201238 200919 201239 200919 201238 201239 Totals* 452 210 0.7 – 30 7 NR NR NR 1-5 1 NR Duration of Use Leave-On 228 168 0.8-30 7 NR NR NR 1-5 1 NR Rinse-Off 224 42 0.7-5 7 NR NR NR NR NR NR Diluted for (Bath) Use NR NR NR NR NR NR NR NR NR NR Exposure Type Eye Area 28 9 3-4 NS NR NR NR 1 NR NR Incidental Ingestion 8 26 3-11.5 NS NR NR NR NR NR NR Incidental Inhalation-Spray 5a 6a NR NS NR NR NR NR NR NR Incidental Inhalation-Powder 1 NR NS NR NR NR NR NR NR NR Dermal Contact 170 156 0.8-5 NS NR NR NR 1-5 1 NR Deodorant (underarm) 1b 5b NR NS NR NR NR NR NR NR Hair - Non-Coloring 269 11 0.7-5 NS NR NR NR 1 NR NR Hair-Coloring 5 15 NR NS NR NR NR NR NR NR Nail NR 1 NR NS NR NR NR NR NR NR Mucous Membrane 11 30 NR NS NR NR NR NR NR NR Baby Products 1 NR NR NS NR NR NR NR NR NR Cetyl Myristate Cetyl Palmitate Cetyl Ricinoleate 201290 200716 201239 200816 201238 20015 201239 19769/20015 201238 200220 201239 200420 Totals* 4 7 NR 6 474 236 0.002-11 0.01-11 130 55 0.3-16 0.1 - 10 Duration of Use Leave-On 4 7 NR 6 431 208 0.002-11 0.0-11 121 50 0.3-15.2 0.1-10 Rinse-Off NR NR NR NR 43 28 0.006-5 0.02-1 9 5 0.3 0.1-0.5 Diluted for (Bath) Use NR NR NR NR NR NR NR NR NR NR NR NR Exposure Type Eye Area 1 1 NR NR 47 54 3-11 0.2-11 12 NR 0.3-5 NR Incidental Ingestion NR NR NR NR 22 10 2-7 10 32 26 2-15.2 0.5-10 Incidental Inhalation-Spray NR NR NR NR 16a 13a,b 0.4a-6; 2a 1a 1a NR NR 8 (pump spray) Incidental Inhalation-Powder NR NR NR NR NR NR 0.8 NR 4 NR NR NR Dermal Contact 4 7 NR 6 442 213 0.002-11 0.02-11 89 29 0.3-6 0.1-4 Deodorant (underarm) NR NR NR NR 2b NR NR 0.3b NR NR NR NR Hair - Non-Coloring NR NR NR NR 10 12 2 1 NR NR NR NR Hair-Coloring NR NR NR NR NR NR 0.8 0.2 NR NR NR NR Nail NR NR NR NR 2 NR 2-7 NR NR NR NR NR Mucous Membrane NR NR NR NR 26 10 0.006-7 0.02-10 32 26 2-15.2 0.5-10 Baby Products NR NR NR NR NR NR NR NR NR NR NR NR

61

Table 8. Frequency and concentration of use (historical and current) according to duration and type of exposure # of Uses Max Conc of Use (%) # of Uses Max Conc of Use (%) # of Uses Max Conc of Use (%) Cetyl Stearate Cetyl Tallowate Coco-Caprylate 201238 20025 201239 198511/ 201238 201239 201238 201239 20035 Totals 5 2 1-4 0.3-15 1 NR 5 NR Duration of Use Leave-On 5 2 4 0.3-15 1 NR 5 NR Rinse Off NR NR 1 0.6-3 NR NR NR NR Diluted for (Bath) Use NR NR NR NR NR NR NR NR Exposure Type Eye Area 2 NR NR 0.6-10 NR NR 1 NR Incidental Ingestion NR 2 NR NR NR NR NR NR Incidental Inhalation-Spray NR NR NR NR NR NR NR NR Incidental Inhalation-Powder NR NR NR >1-5 NR NR NR NR Dermal Contact 5 NR NR 0.3-15 1 NR NR NR Deodorant (underarm) NR NR NR NR NR NR NR NR Hair - Non-Coloring NR NR 1-4 2-3 NR NR NR NR Hair-Coloring NR NR NR NR NR NR NR NR Nail NR NR NR NR NR NR NR NR Mucous Membrane NR 2 NR NR NR NR NR NR Baby Products NR NR NR NR NR NR NR NR Coco-Caprylate/Caprate Decyl Cocoate Decyl Oleate 201238 201239 201238 200717 201239 200817 201238 20014 201239 197636/ 20014 Totals 232 0.5-62 5 NR NR NR 200 147 0.5-20 ≤0.1-88 Duration of Use Leave-On 204 0.5-35 3 NR NR NR 185 121 0.5-4 0.5-88 Rinse Off 22 1-62 2 NR NR NR 15 25 2-20 ≤0.1-25 Diluted for (Bath) Use 6 NR NR NR NR NR NR 1 NR >5-25 Exposure Type Eye Area 26 0.7-35 NR NR NR NR 6 NR 20 >1- >50 Incidental Ingestion 2 0.5-9 NR NR NR NR NR 1 NR 8 Incidental Inhalation-Spray 15a 2-6a NR NR NR NR 1 3 2 (pump >0.1-1 spray) (spray); >1-88a,b Incidental Inhalation-Powder 1 4-16 NR NR NR NR NR 1 NR NR Dermal Contact 229 0.5-62 5 NR NR NR 189 137 0.5-20 ≤0.1-88 Deodorant (underarm) NR NR NR NR NR NR 1b 1b NR NR Hair - Non-Coloring 1 30 NR NR NR NR 10 6 2-3 >0.1-1 Hair-Coloring NR NR NR NR NR NR NR NR 2 3 Nail NR NR NR NR NR NR 1 3 NR >5-10 Mucous Membrane 9 0.5-9 NR NR NR NR NR 1 NR >5-88 Baby Products NR NR NR NR NR NR NR NR NR >1-5 Decyl Olivate Ethylhexyl Cocoate Ethylhexyl Hydroxystearate 201238 201239 201238 200717 201239 200817 201238 201239 Totals* 1 NR 89 18 0.0006-41 0.01-41 253 0.09-18 Duration of Use Leave-On 1 NR 77 17 0.0006-41 0.01-41 228 0.1-18 Rinse-Off NR NR 12 1 5-9 3-5 25 0.09-3 Diluted for (Bath) Use NR NR NR NR 6 6 NR 3 Exposure Type Eye Area NR NR 10 5 12 0.02-2 16 2-8 Incidental Ingestion NR NR 4 NR 8 0.01-19 79 2-18 Incidental Inhalation-Spray NR NR 11a 1 NR 4-10a 3a NR Incidental Inhalation-Powder NR NR NR NR NR NR 1 NR Dermal Contact 1 NR 80 16 2-41 0.02-41 150 0.1-9 Deodorant (underarm) NR NR NR NR NR 5b NR NR Hair - Non-Coloring NR NR 2 2 NR NR 4 0.09-2 Hair-Coloring NR NR NR NR NR NR NR NR Nail NR NR 3 NR 0.0006 NR NR NR Mucous Membrane NR NR 5 NR 8 0.01-19 91 0.2-18 Baby Products NR NR NR NR NR 5 NR NR

62

Table 8. Frequency and concentration of use (historical and current) according to duration and type of exposure # of Uses Max Conc of Use (%) # of Uses Max Conc of Use (%) # of Uses Max Conc of Use (%) Ethylhexyl Isononanoate Ethylhexyl Isopalmitate Ethylhexyl Isostearate 201238 200919 201239 200919 201238 201239 201238 201239 Totals* 137 116 0.02-75 0.02-74 6 NR 6 27-40 Duration of Use Leave-On 134 112 0.02-75 0.02-74 6 NR 6 27-40 Rinse-Off 3 4 0.3-20 0.8-1 NR NR NR NR Diluted for (Bath) Use NR NR NR NR NR NR NR NR Exposure Type Eye Area 6 0.8-20 0.8-65 1 NR 6 27-40 Incidental Ingestion 1 9 2 NR NR NR NR NR Incidental Inhalation-Spray 4 27a,b 0.02-0.1a; 18 1a NR NR NR 2; 4 (pump 0.03-7a,b spray) Incidental Inhalation-Powder 2 NR NR 3 NR NR NR NR Dermal Contact 131 102 0.02-75 0.02-74 6 NR 1 27-40 Deodorant (underarm) NR NR 3 (not NR NR NR NR NR spray) Hair - Non-Coloring 5 4 8 0.8-8 NR NR NR NR Hair-Coloring NR NR NR NR NR NR NR NR Nail NR NR NR NR NR NR NR NR Mucous Membrane 2 10 2 NR NR NR NR NR Baby Products NR NR NR NR NR NR NR NR Ethylhexyl Laurate Ethylhexyl Myristate Ethylhexyl Olivate 201238 201239 201238 200716 201239 200816 201238 201239 Totals* 1 NR 2 NR NR NR 2 NR Duration of Use Leave-On 1 NR 1 NR NR NR 2 NR Rinse-Off NR NR 1 NR NR NR NR NR Diluted for (Bath) Use NR NR NR NR NR NR NR NR Exposure Type Eye Area NR NR NR NR NR NR 1 NR Incidental Ingestion NR NR NR NR NR NR NR NR Incidental Inhalation-Spray NR NR NR NR NR NR NR NR Incidental Inhalation-Powder NR NR NR NR NR NR NR NR Dermal Contact 1 NR 2 NR NR NR 2 NR Deodorant (underarm) NR NR NR NR NR NR NR NR Hair - Non-Coloring NR NR NR NR NR NR NR NR Hair-Coloring NR NR NR NR NR NR NR NR Nail NR NR NR NR NR NR NR NR Mucous Membrane NR NR NR NR NR NR NR NR Baby Products NR NR NR NR NR NR NR NR Ethylhexyl Palmitate Ethylhexyl Pelargonate Ethylhexyl Stearate 201238 20015 201239 19769/ 201238 200919 201239 200919 201238 20025 201239 198511/ 20015 20035 Totals 1298 417 0.0003-78 0.1 - >50 3 3 2-4 2-25 318 31 0.0004-38 >0.1-25 Duration of Use Leave-On 1246 407 0.0003-78 0.1 - >50 2 2 2 3-25 286 27 0.0004-38 >0.1-25 Rinse Off 50 10 0.05-50 2-21 1 1 3-4 2-5 27 2 0.1-29 NR Diluted for (Bath) Use 2 NR 10 6-23 NR NR NR NR 5 2 NR >0.1-5 Exposure Type Eye Area 281 141 0.01-50 0.2- >50 NR NR NR 2 39 5 0.003-38 0.8-11 Incidental Ingestion 210 100 NR 4-42 NR NR NR NR 6 1 19-27.1 NR Incidental Inhalation-Spray 51a 2b 3-16; 4-45 21 (spray) NR NR NR NR 16a 5a,b 2-10a NR (aerosol); 0.4 0.5- >50a,b (pump spray) Incidental Inhalation-Powder 67 13 0.3-10 0.3-22 NR NR NR NR 9 2 6 0.5 Dermal Contact 1264 314 0.003-78 0.1- >50 3 3 2 2-25 303 31 0.0004-38 >0.1-25 Deodorant (underarm) 6 1 1 (aerosol) 2b NR NR NR NR NR NR NR NR Hair - Non-Coloring 18 NR 2-4 2-17 NR NR NR NR 9 NR 5 NR Hair-Coloring NR NR NR NR NR NR 3-4 5 NR NR 29 NR Nail 15 3 5-50 5-28 NR NR NR NR NR NR NR NR Mucous Membrane 216 100 1-10 4-42 NR NR NR NR 15 3 5-27.1 >0.1-5 Baby Products 2 NR NR NR NR NR NR NR NR NR NR NR

63

Table 8. Frequency and concentration of use (historical and current) according to duration and type of exposure # of Uses Max Conc of Use (%) # of Uses Max Conc of Use (%) # of Uses Max Conc of Use (%) Heptyl Undecylenate Heptylundecyl Hydroxystearate Hexyl Isostearate 201238 201239 201238 201239 201238 201239 Totals* 3 0.01-26 10 20 NR 0.008-0.04 Duration of Use Leave-On 3 0.01-26 10 20 NR 0.008-0.04 Rinse-Off NR 0.01-0.1 NR NR NR NR Diluted for (Bath) Use NR NR NR NR NR NR Exposure Type Eye Area 3 26 8 NR NR NR Incidental Ingestion NR NR 2 20 NR NR Incidental Inhalation-Spray NR 0.01 (pump spray) NR NR NR NR Incidental Inhalation-Powder NR NR NR NR NR NR Dermal Contact 3 10-26 8 NR NR 0.008 Deodorant (underarm) NR NR NR NR NR NR Hair - Non-Coloring NR 0.01-0.1 NR NR NR NR Hair-Coloring NR NR NR NR NR NR Nail NR NR NR NR NR 0.04 Mucous Membrane NR NR 2 20 NR NR Baby Products NR NR NR NR NR NR Hexyl Laurate Hexyldecyl Isostearate Hexyldecyl Laurate 201238 201239 201238 201239 201238 201239 Totals* 182 0.07-3 NR 0.2-2 39 1-2 Duration of Use Leave-On 179 0.07-3 NR 2 33 2 Rinse-Off 3 2 NR 0.2-7 6 2 Diluted for (Bath) Use NR NR NR NR NR NR Exposure Type Eye Area 16 0.3-3 NR NR 2 NR Incidental Ingestion 15 0.1-2 NR NR NR NR Incidental Inhalation-Spray 12a 0.07-0.1 NR NR NR NR Incidental Inhalation-Powder 1 2 NR NR NR NR Dermal Contact 177 0.07-3 NR 0.2-2 36 1-2 Deodorant (underarm) NR NR NR NR NR NR Hair - Non-Coloring 2 2-3 NR 0.7-2 5 2 Hair-Coloring NR NR NR NR NR NR Nail 1 2 NR NR NR NR Mucous Membrane 15 0.1-2 NR NR NR NR Baby Products 3 NR NR NR NR NR Hexyldecyl Stearate Hydrogenated Ethylhexyl Olivate Hydroxyoctacosanyl Hydroxystearate 201238 201239 201238 201239 201238 201239 Totals 32 0.5-13 7 0.05-15.5 5 NR Duration of Use Leave-On 23 0.5-13 6 4-15.5 5 NR Rinse Off 9 3 1 0.05 NR NR Diluted for (Bath) Use NR NR NR NR NR NR Exposure Type Eye Area 2 3 2 4 1 NR Incidental Ingestion NR 0.9 NR NR NR NR Incidental Inhalation-Spray NR NR NR 15.5 (pump spray) NR NR Incidental Inhalation-Powder NR NR NR NR NR NR Dermal Contact 32 0.5-13 6 4-7 5 NR Deodorant (underarm) NR NR NR NR NR NR Hair - Non-Coloring NR NR 1 0.05-15.5 NR NR Hair-Coloring NR NR NR NR NR NR Nail NR NR NR NR NR NR Mucous Membrane NR NR NR NR NR NR Baby Products NR NR NR NR NR NR

64

Table 8. Frequency and concentration of use (historical and current) according to duration and type of exposure # of Uses Max Conc of Use (%) # of Uses Max Conc of Use (%) # of Uses Max Conc of Use (%) Isoamyl Laurate Isobutyl Myristate Isobutyl Stearate Totals 201238 201239 201238 200716 201239 200816 201238 20025 201239 20035 Duration of Use NR 1-2 NR NR NR 3-30 NR 3 NR 7 Leave-On NR 1 NR NR NR 3-30 NR 2 NR 7 Rinse Off NR 2 NR NR NR 10 NR 1 NR NR Diluted for (Bath) Use NR NR NR NR NR NR NR NR NR NR Exposure Type Eye Area NR NR NR NR NR NR NR NR NR NR Incidental Ingestion NR NR NR NR NR NR NR NR NR NR Incidental Inhalation-Spray NR NR NR NR NR 3a NR NR NR NR Incidental Inhalation-Powder NR NR NR NR NR NR NR NR NR NR Dermal Contact NR NR NR NR NR 3-30 NR 3 NR 7 Deodorant (underarm) NR 1-2 NR NR NR NR NR NR NR NR Hair - Non-Coloring NR NR NR NR NR NR NR NR NR NR Hair-Coloring NR NR NR NR NR NR NR NR NR NR Nail NR NR NR NR NR NR NR NR NR NR Mucous Membrane NR NR NR NR NR NR NR 1 NR NR Baby Products NR NR NR NR NR NR NR NR NR NR Isocetyl Myristate Isocetyl Palmitate Isocetyl Stearate 201238 200716 201239 200816 201238 201239 201238 20025 201239 198511/ 20035 Totals 10 6 0.4-37 NR 5 NR 202 84 0.1-34 0.02-30 Duration of Use Leave-On 9 NR 0.4-36.5 NR 5 NR 189 77 0.1-34 0.1-30 Rinse Off 1 NR NR NR NR NR 13 7 0.6-5 0.02-30 Diluted for (Bath) Use NR NR NR NR NR NR NR NR NR NR Exposure Type Eye Area 3 NR NR NR NR NR 2 2 0.1-16 30 Incidental Ingestion NR NR NR NR NR NR 14 4 0.3-24 0.1-24 Incidental Inhalation-Spray NR NR NR NR NR NR 3a NR 0.6a 10 34 (pump spray) Incidental Inhalation-Powder 1 NR 0.4-2 NR NR NR 4 NR NR >1-25 Dermal Contact 10 NR 0.4-36.5 NR 5 NR 188 79 0.1-34 0.02-30 Deodorant (underarm) NR NR NR NR NR NR NR NR NR 3 Hair - Non-Coloring NR NR NR NR NR NR 8 NR 0.5-1 NR Hair-Coloring NR NR NR NR NR NR NR NR 0.6 NR Nail NR NR NR NR NR NR NR 1 NR >1-5 Mucous Membrane NR NR NR NR NR NR 15 4 0.3-24 0.1-30 Baby Products NR NR NR NR NR NR NR NR NR NR Isodecyl Cocoate Isodecyl Isononanoate Isodecyl Laurate 201238 200717 201239 200817 201238 200919 201239 200919 201238 201239 Totals* NR NR 2 NR 36 26 1-43.5 0.05-59 4 NR Duration of Use Leave-On NR NR 2 NR 33 24 1-43.5 0.05-59 2 NR Rinse-Off NR NR NR NR 3 2 10 2-10 2 NR Diluted for (Bath) Use NR NR NR NR NR NR NR NR NR NR Exposure Type Eye Area NR NR NR NR 8 2 1-40 6-21 2 NR Incidental Ingestion NR NR NR NR 4 NR 40-43.5 0.05-18 NR NR Incidental Inhalation-Spray NR NR NR NR 2a 2a NR 5a NR NR Incidental Inhalation-Powder NR NR NR NR NR NR NR NR NR NR Dermal Contact NR NR 2 NR 32 25 1-40 2-59 4 NR Deodorant (underarm) NR NR NR NR NR NR NR NR NR NR Hair - Non-Coloring NR NR NR NR NR 1 NR 2 NR NR Hair-Coloring NR NR NR NR NR NR NR NR NR NR Nail NR NR NR NR NR NR NR NR NR NR Mucous Membrane NR NR NR NR 4 NR 40-43.5 0.05-18 NR NR Baby Products NR NR NR NR NR NR NR NR NR NR

65

Table 8. Frequency and concentration of use (historical and current) according to duration and type of exposure # of Uses Max Conc of Use (%) # of Uses Max Conc of Use (%) # of Uses Max Conc of Use (%) Isodecyl Myristate Isodecyl Neopentanoate Isodecyl Oleate 201238 200716 201239 200816 201238 201239 201238 20014 201239 197636/ 20014 Totals* 1 1 NR NR 126 0.05-17 15 44 0.07-4 >0.1 – 25 Duration of Use Leave-On 1 1 NR NR 121 0.05-17 14 37 0.07-4 >1 - 25 Rinse-Off NR NR NR NR 5 0.1-2 1 7 2-3 >1 - 25 Diluted for (Bath) Use NR NR NR NR NR NR NR NR NR >0.1 - 10 Exposure Type Eye Area 1 NR NR NR 25 1-17 NR 1 2 >1 - 5 Incidental Ingestion NR NR NR NR 8 0.6-5 NR 22 0.07 4-8 Incidental Inhalation-Spray NR NR NR NR 7a 3 3 1 4 (aerosol) 3a 0.5 (aerosol) 2 (pump 0.3 (pump spray) spray) Incidental Inhalation-Powder NR NR NR NR 4 2 NR NR NR NR Dermal Contact 1 1 NR NR 116 0.05-17 4 17 2-3 >0.1-25 Deodorant (underarm) NR NR NR NR NR NR NR NR NR >1-5 Hair - Non-Coloring NR NR NR NR 1 0.3-2 10 4 2-4 2 Hair-Coloring NR NR NR NR NR NR NR NR NR NR Nail NR NR NR NR NR NR 1 1 NR NR Mucous Membrane NR NR NR NR 8 0.6-5 NR 22 0.07 >0.1-10 Baby Products NR NR NR NR NR 3 NR NR NR NR Isohexyl Caprate Isononyl Isononanoate Isopropyl Hydroxystearate 201238 201239 201238 200919 201239 200919 201238 201239 Totals* 3 NR 611 343 0.07-53 0.03-64 NR 8 Duration of Use Leave-On 3 NR 588 328 0.07-53 0.04-64 NR 8 Rinse-Off NR NR 23 15 0.3-25 0.03 NR NR Diluted for (Bath) Use NR NR NR NR 15 15 NR NR Exposure Type Eye Area NR NR 80 47 0.8-53 2-26 NR 8 Incidental Ingestion NR NR 47 28 5-47 8-50 NR NR Incidental Inhalation-Spray NR NR 32a 20a,b 0.1-6a; 26- 0.4-6; NR NR 45 0.08-21a; 0.4 (pump 21-46b spray) Incidental Inhalation-Powder NR NR 28 12 4-9 2-15 NR NR Dermal Contact 3 NR 559 314 0.07-53 0.04-64 NR 8 Deodorant (underarm) NR NR 1b 1b 7 (not 3b NR NR spray) 7 (aerosol) Hair - Non-Coloring NR NR 3 1 0.4-1 0.08-7 NR NR Hair-Coloring NR NR NR NR NR 33 NR NR Nail NR NR 2 NR 6 0.4-5 NR NR Mucous Membrane NR NR 48 29 5-47 8-50 NR NR Baby Products NR NR NR NR 3 NR NR NR Isopropyl Isostearate Isopropyl Jojobate Isopropyl Linoleate 201238 20058 201239 198921/ 201238 201239 201238 198815 201239 198815 20078 Totals 225 69 0.5-19 ≤0.1-65 22 0.3-6 NR 21c 0.1 >0.1–10c Duration of Use Leave-On 212 63 0.5-19 ≤0.1-30 22 0.3-6 NR NS 0.1 NS Rinse Off 13 6 0.7-6 2-65 NR NR NR NS 0.1 NS Diluted for (Bath) Use NR NR NR NR NR NR NR NS NR NS Exposure Type Eye Area 59 9 0.8-10 0.6-8 2 0.7 NR NS NR NS Incidental Ingestion 18 NR 15-17 12-24 3 NR NR NS NR NS Incidental Inhalation-Spray 7a NR 0.6 (pump NR 1a NR NR NS NR NS spray) Incidental Inhalation-Powder 16 2 2-19 0.6-30 NR NR NR NS 0.1 NS Dermal Contact 203 68 0.5-19 ≤0.1-30 19 0.7-6 NR NS 0.1 NS Deodorant (underarm) NR NR NR 5 NR NR NR NS NR NS Hair - Non-Coloring 3 1 0.5-0.8 65 NR NR NR NS 0.1 NS Hair-Coloring NR NR NR NR NR NR NR NS NR NS Nail NR NR NR NR NR NR NR NS NR NS Mucous Membrane 19 NR 15-17 12-24 3 NR NR NS NR NS Baby Products 2 2 NR NR NR NR NR NS NR NS

66

Table 8. Frequency and concentration of use (historical and current) according to duration and type of exposure # of Uses Max Conc of Use (%) # of Uses Max Conc of Use (%) # of Uses Max Conc of Use (%) Isopropyl Myristate Isopropyl Palmitate Isopropyl Ricinoleate 201238 200716 201239 200816 201238 20015 201239 19769 201238 200220 201239 200420 /20015 Totals 1149 1057 0.000005- 0.001-82 999 535 0.0001-60 0.000002 - NR NR 2 NR 77.3 >50 Duration of Use Leave-On 932 874 0.0002-77.3 0.001-82 888 434 0.0001-60 0.00001 - NR NR 2 NR >50 Rinse Off 202 160 0.000005-67 0.4-60 85 81 0.0003-31 0.000002- NR NR NR NR 11 Diluted for (Bath) Use 15 23 1-22 2-23 26 20 0.001-60 0.3-60 NR NR NR NR Exposure Type Eye Area 130 99 0.9-31 0.04-20 72 19 0.1-34 0.25-10 NR NR NR NR Incidental Ingestion 53 49 2-18 1-26 104 80 1-34 5-25 NR NR 2 NR Incidental Inhalation-Spray 72a 55 0.6-36a 0.02-10 47a 43a,b 0.4-5a; 0.2-60a,b NR NR NR NR 0.02-76.6 1-58b 9-60b (aerosol) 0.8-17 (aero- sol); 3-20 (pump spray) Incidental Inhalation-Powder 24 19 0.7-3 0.3-4 33 12 3-18 0.00001 - NR NR NR NR 14 Dermal Contact 923 893 0.0003-60 0.001-82 829 415 0.0001-60 0.000002 - NR NR NR NR >50 Deodorant (underarm) 20b 10 0.0003-23 0.08-51 15 1b 0.5-17 (not 0.0023-17b NR NR NR NR (not spray) spray) 0.03-23 (aer- 3-5 (aerosol) osol) 8 (pump spray) Hair - Non-Coloring 143 107 0.000005- 0.02-48 33 17 0.0003-20 0.00005 – NR NR NR NR 77.3 12 Hair-Coloring 21 5 30-68 22-30 NR 16 44 >0.1 - 1 NR NR NR NR (11-22 after dilution) Nail 9 7 0.05-38 3-38 14 6 0.5-12 0.06-10 NR NR NR NR Mucous Membrane 111 91 1-22 1-60 139 91 0.05-34 0.00001 - NR NR 2 NR 60 Baby Products 6 4 17 3 4 4 2-11 5 NR NR NR NR Isopropyl Stearate Isostearyl Avocadate Isostearyl Behenate 201238 20025 201239 198511/ 201238 201239 201238 201239 20035 Totals* 10 16 0.9-16 0.5-87 1 NR 7 4 Duration of Use Leave-On 9 12 1-16 0.5-50 1 NR 7 4 Rinse-Off 1 4 0.9-9 6-87 NR NR NR NR Diluted for (Bath) Use NR NR 7 >5-10 NR NR NR NR Exposure Type Eye Area 1 3 2 5-76 NR NR NR NR Incidental Ingestion NR NR 16 87 NR NR NR NR Incidental Inhalation-Spray NR NR NR >25-50b NR NR NR NR Incidental Inhalation-Powder NR NR NR NR NR NR NR NR Dermal Contact 10 16 1-9 0.5-76 1 NR 7 4 Deodorant (underarm) 1b NR NR 3 NR NR NR NR Hair - Non-Coloring NR NR NR 6-8 NR NR NR NR Hair-Coloring NR NR NR NR NR NR NR NR Nail NR NR 0.9 10 NR NR NR NR Mucous Membrane NR NR 16 87 NR NR NR NR Baby Products NR NR NR NR NR NR NR NR

67

Table 8. Frequency and concentration of use (historical and current) according to duration and type of exposure # of Uses Max Conc of Use (%) # of Uses Max Conc of Use (%) # of Uses Max Conc of Use (%) Isostearyl Hydroxystearate Isostearyl Isononanoate Isostearyl Isostearate 201238 201239 201238 200919 201239 200919 201238 201239 Totals* 21 0.01-3 4 NR NR NR 194 1-31 Duration of Use Leave-On 21 0.01-3 3 NR NR NR 181 1-31 Rinse-Off NR NR 1 NR NR NR 12 NR Diluted for (Bath) Use NR NR NR NR NR NR 1 NR Exposure Type Eye Area 7 3 NR NR NR NR 3 4 Incidental Ingestion NR NR NR NR NR NR 114 4-31 Incidental Inhalation-Spray NR NR NR NR NR NR 1 NR Incidental Inhalation-Powder 3 0.01 NR NR NR NR NR NR Dermal Contact 14 0.01-3 NR NR NR NR 75 1-30 Deodorant (underarm) NR NR NR NR NR NR NR NR Hair - Non-Coloring NR NR NR NR NR NR NR NR Hair-Coloring NR NR NR NR NR NR NR NR Nail NR NR 9 NR NR NR NR NR Mucous Membrane 7 NR NR NR NR NR 115 4-31 Baby Products NR NR NR NR NR NR NR NR Isostearyl Laurate Isostearyl Linoleate Isostearyl Myristate 201238 201239 201238 201239 201238 200716 201290 201239 Totals* NR 0.4 2 2-3 1 NR 2 NR Duration of Use Leave-On NR NR 2 2-3 1 NR 2 NR Rinse-Off NR 0.4 NR NR NR NR NR NR Diluted for (Bath) Use NR NR NR NR NR NR NR NR Exposure Type Eye Area NR NR NR NR NR NR NR NR Incidental Ingestion NR NR NR 2 NR NR NR NR Incidental Inhalation-Spray NR NR NR NR NR NR NR NR Incidental Inhalation-Powder NR NR 1 NR NR NR NR NR Dermal Contact NR 0.4 2 2-3 1 NR 2 NR Deodorant (underarm) NR NR NR NR NR NR NR NR Hair - Non-Coloring NR NR NR NR NR NR NR NR Hair-Coloring NR NR NR NR NR NR NR NR Nail NR NR NR NR NR NR NR NR Mucous Membrane NR NR NR 2 NR NR NR NR Baby Products NR NR NR NR NR NR NR NR Isostearyl Neopentanoate Isostearyl Palmitate Isotridecyl Isononanoate 201238 20026 201239 198112 201238 201239 201238 200919 201239 200919 20036 Totals 225 71 0.5-46 0.2-50 48 0.2-17 77 62 1-21 0.7-51 Duration of Use Leave-On 210 66 0.5-46 0.2-50 41 0.2-17 77 62 1-21 0.7-51 Rinse Off 15 4 5-16 >5-25 7 0.5-8 NR NR 3-4 NR Diluted for (Bath) Use NR NR NR NR NR NR NR NR NR NR Exposure Type Eye Area 78 7 3-30 1-25 7 0.2-5 5 NR 2-21 0.7 Incidental Ingestion 8 3 4-19 9-14 3 5-8 17 19 2 10 Incidental Inhalation-Spray 4a 6a,b 0.5 (pump 2-4a 3a NR 3a NR NR 0.8a spray) Incidental Inhalation-Powder 34 3 1-16 3-6 8 1-16 6 6 2 10 Dermal Contact 211 68 0.5-46 0.2-50 39 0.2-17 60 43 1-21 0.7-51 Deodorant (underarm) NR NR NR NR NR NR NR NR NR NR Hair - Non-Coloring 13 NR 16 NR 6 NR NR NR 3 3 Hair-Coloring NR NR NR NR NR NR NR NR NR NR Nail 1 NR NR NR NR 1 NR NR NR NR Mucous Membrane 8 3 4-19 9-14 3 0.5-8 17 19 2 10 Baby Products NR NR NR NR NR NR NR NR NR NR

68

Table 8. Frequency and concentration of use (historical and current) according to duration and type of exposure # of Uses Max Conc of Use (%) # of Uses Max Conc of Use (%) # of Uses Max Conc of Use (%) Isotridecyl Stearate Lauryl Laurate Lauryl Palmitate 201238 201239 201238 201239 201238 201239 Totals* 1 NR 30 0.1-16 2 NR Duration of Use Leave-On 1 NR 30 0.1-16 1 NR Rinse-Off NR NR NR NR 1 NR Diluted for (Bath) Use NR NR NR NR NR NR Exposure Type Eye Area 1 NR 2 0.8-16 NR NR Incidental Ingestion NR NR 1 NR NR NR Incidental Inhalation-Spray NR NR 3 NR NR NR Incidental Inhalation-Powder NR NR NR 0.1 NR NR Dermal Contact 1 NR 27 0.1-16 1 NR Deodorant (underarm) NR NR NR NR NR NR Hair - Non-Coloring NR NR 1 NR 1 NR Hair-Coloring NR NR NR NR NR NR Nail NR NR 1 NR NR NR Mucous Membrane NR NR 1 NR NR NR Baby Products NR NR NR NR NR NR Myristyl Laurate Myristyl Myristate Myristyl Neopentanoate 201238 201239 201238 200716 201239 200816 201238 201239 Totals* 10 0.1-2 402 304 0.5-17 0.3-17 NR 2 Duration of Use Leave-On 9 0.2-2 360 271 0.5-17 0.4-17 NR 2 Rinse-Off 1 0.1-0.7 38 28 0.5-4 0.3-2 NR NR Diluted for (Bath) Use NR NR 4 5 1-2 NR NR NR Exposure Type Eye Area 1 0.4-2 58 34 1-12 0.4-13 NR 2 Incidental Ingestion 1 2 30 18 1-12 6-9 NR NR Incidental Inhalation-Spray NR 0.2a 15a 9a,b 0.5-0.8a; 2- 2-17a,b NR NR 17 Incidental Inhalation-Powder NR NR 6 NR 2-5 NR NR NR Dermal Contact 9 0.1-2 354 269 0.5-17 0.3-17 NR 2 Deodorant (underarm) NR NR 14b 6b 2 (not a 2b NR NR spray) Hair - Non-Coloring NR 0.4-0.5 17 13 0.5-8 2 NR NR Hair-Coloring NR NR NR NR 1 NR NR NR Nail NR NR 1 4 1-7 2-3 NR NR Mucous Membrane 1 2 35 23 1-12 3-9 NR NR Baby Products NR NR 4 15 2-3 1-2 NR NR Myristyl Stearate Octyldodecyl Erucate Octyldodecyl Hydroxystearate 201238 20025 201239 198511/ 201238 201239 201238 201239 20035 Totals* 2 NR NR >1-5 1 0.01-10 1 NR Duration of Use Leave-On 2 NR NR >1-5 1 0.01-10 1 NR Rinse-Off NR NR NR NR NR 0.01-0.1 NR NR Diluted for (Bath) Use NR NR NR NR NR NR NR NR Exposure Type Eye Area NR NR NR NR NR 0.01-0.2 1 NR Incidental Ingestion NR NR NR NR NR 10 NR NR Incidental Inhalation-Spray NR NR NR NR NR NR NR NR Incidental Inhalation-Powder NR NR NR NR NR 0.1 NR NR Dermal Contact 2 NR NR >1-5 1 0.1-1 1 NR Deodorant (underarm) NR NR NR NR NR NR NR NR Hair - Non-Coloring NR NR NR NR NR NR NR NR Hair-Coloring NR NR NR NR NR NR NR NR Nail NR NR NR 4 NR 0.01 NR NR Mucous Membrane NR NR NR NR NR 10 NR NR Baby Products NR NR NR NR NR NR NR NR

69

Table 8. Frequency and concentration of use (historical and current) according to duration and type of exposure # of Uses Max Conc of Use (%) # of Uses Max Conc of Use (%) # of Uses Max Conc of Use (%) Octyldodecyl Isostearate Octyldodecyl Myristate Octyldodecyl Neopentanoate 201238 201239 201238 200716 201239 200816 201238 201239 Totals* 1 2 142 95 0.05-32 0.007-21 107 0.5-20 Duration of Use Leave-On 1 2 130 88 0.05-32 0.07-21 105 0.5-20 Rinse-Off NR NR 12 7 0.4-3 NR 2 3 Diluted for (Bath) Use NR NR NR NR NR NR NR NR Exposure Type Eye Area NR 2 16 7 0.05-2 0.3-2 20 1-9 Incidental Ingestion 1 NR 19 10 0.08-21 0.07-21 16 0.7-12 Incidental Inhalation-Spray NR NR 11a 7a NR 1a 7a 7a 20 (pump spray) Incidental Inhalation-Powder NR NR 3 2 NR NR 2 2-4 Dermal Contact NR 2 138 83 0.05-32 0.007-12 89 0.8-20 Deodorant (underarm) NR NR NR NR NR NR NR NR Hair - Non-Coloring NR NR 2 1 3 NR 9 0.5 Hair-Coloring NR NR NR NR NR NR NR NR Nail NR NR NR NR NR NR NR NR Mucous Membrane 1 NR 19 10 0.08-21 0.07-21 16 0.7-12 Baby Products NR NR 2 2 NR NR NR NR Octyldodecyl Octyldodecanoate Octyldodecyl Olivate Octyldodecyl Ricinoleate 201238 201239 201238 201239 201238 200220 201239 200420 Totals 1 4 11 2 11 NR 0.9-3 3-5 Duration of Use Leave-On 1 4 11 2 6 NR 0.9-3 3-5 Rinse Off NR NR NR NR 5 NR NR NR Diluted for (Bath) Use NR NR NR NR NR NR NR NR Exposure Type Eye Area NR NR 2 NR NR NR NR NR Incidental Ingestion NR NR NR NR NR NR 0.9-3 3-5 Incidental Inhalation-Spray NR NR NR NR NR NR NR 3a Incidental Inhalation-Powder NR NR NR NR NR NR NR NR Dermal Contact 1 4 11 2 3 NR 3 3 Deodorant (underarm) NR NR NR NR NR NR NR NR Hair - Non-Coloring NR NR NR NR 8 NR NR NR Hair-Coloring NR NR NR NR NR NR NR NR Nail NR NR NR NR NR NR NR NR Mucous Membrane NR NR NR NR NR NR 0.9-3 3-5 Baby Products NR NR NR NR NR NR NR NR Octyldodecyl Stearate Oleyl Erucate Oleyl Linoleate 201238 201239 201238 201239 201238 201239 Totals 29 3-19 44 1-12 NR 10-11 Duration of Use Leave-On 29 3-19 40 1-12 NR 10-11 Rinse Off NR NR 4 NR NR 10 Diluted for (Bath) Use NR NR NR NR NR NR Exposure Type Eye Area 21 4-19 1 12 NR NR Incidental Ingestion 2 9 16 NR NR 10 Incidental Inhalation-Spray NR NR 8a NR NR NR Incidental Inhalation-Powder 1 NR NR 11 NR NR Dermal Contact 27 3-19 27 1-12 NR 10 Deodorant (underarm) NR NR NR NR NR NR Hair - Non-Coloring NR NR 1 NR NR NR Hair-Coloring NR NR NR NR NR NR Nail NR NR NR NR NR NR Mucous Membrane 2 9 17 NR NR 11 Baby Products NR NR NR NR NR NR

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Table 8. Frequency and concentration of use (historical and current) according to duration and type of exposure # of Uses Max Conc of Use (%) # of Uses Max Conc of Use (%) # of Uses Max Conc of Use (%) Oleyl Oleate Propylheptyl Caprylate Stearyl Beeswax 201238 201239 201238 201239 201238 201239 Totals 11 0.4-9 24 1-13 10 0.4 Duration of Use Leave-On 10 0.4-9 23 2-13 9 0.4 Rinse Off 1 1 1 1 1 NR Diluted for (Bath) Use NR NR NR NR NR NR Exposure Type Eye Area 3 NR NR NR NR 0.4 Incidental Ingestion 4 9 9 13 NR NR Incidental Inhalation-Spray NR NR 2a 5 NR NR Incidental Inhalation-Powder 3 NR NR NR NR NR Dermal Contact 7 0.4-3 14 2-6 10 0.4 Deodorant (underarm) NR NR NR NR NR NR Hair - Non-Coloring NR NR 1 1 NR NR Hair-Coloring NR NR NR NR NR NR Nail NR NR NR NR NR NR Mucous Membrane 4 9 9 13 NR NR Baby Products NR NR NR NR NR NR Stearyl Behenate Stearyl Caprylate Stearyl Heptanoate 201238 201018 201239 201018 201238 201018 201239 201018 201238 201018 201239 19933/ 201018 Totals NR NR NR 0.02 28 20 0.3-5 0.1-1 95 102 0.6-11 0.07-25 Duration of Use Leave-On NR NR NR 0.02 27 19 0.3-5 0.3-1 91 99 0.6-11 0.07-25 Rinse Off NR NR NR NR 1 1 NR 0.1-0.6 4 3 2-7 0.7-3 Diluted for (Bath) Use NR NR NR NR NR NR NR NR NR NR NR NR Exposure Type Eye Area NR NR NR 0.02 5 2 0.3-1 ≤1 18 NR 0.6-11 0.5-8 Incidental Ingestion NR NR NR NR 2 2 0.5 NR 11 8 2-11 5-25 Incidental Inhalation-Spray NR NR NR NR NR NR 0.5a NR 1 1 NR NR Incidental Inhalation-Powder NR NR NR NR NR NR NR NR NR NR 2 NR Dermal Contact NR NR NR NR 26 20 0.3-5 ≤1 82 92 0.6-11 0.07-25 Deodorant (underarm) NR NR NR NR NR NR NR NR NR NR NR 0.07b Hair - Non-Coloring NR NR NR NR NR NR 3 NR 2 2 2-3 NR Hair-Coloring NR NR NR NR NR NR NR NR NR NR NR NR Nail NR NR NR NR NR NR NR NR NR NR NR NR Mucous Membrane NR NR NR NR 3 3 0.5 NR 14 8 2-11 5-25 Baby Products NR NR NR NR NR NR NR NR NR NR NR NR Stearyl Olivate Stearyl Palmitate Stearyl Stearate 201238 201018 201239 201018 201238 201018 201239 201018 201238 201018 201239 201018 Totals 3 1 NR NR NR NR 0.02-0.6 3 26 22 0.02-3 0.02-4 Duration of Use Leave-On 1 NR NR NR NR NR 0.02-0.6 3 24 20 0.02-3 0.02-4 Rinse Off 2 1 NR NR NR NR NR NR 2 2 2 2 Diluted for (Bath) Use NR NR NR NR NR NR NR NR NR NR NR NR Exposure Type Eye Area NR NR NR NR NR NR 0.02-0.6 3 5 5 0.2 ≤1 Incidental Ingestion NR NR NR NR NR NR NR NR 5 5 0.3-0.9 ≤1 Incidental Inhalation-Spray NR NR NR NR NR NR NR NR 2 1 NR NR Incidental Inhalation-Powder NR NR NR NR NR NR NR NR NR NR NR NR Dermal Contact 3 1 NR NR NR NR NR NR 19 16 0.02-2 ≤4 Deodorant (underarm) NR NR NR NR NR NR NR NR NR NR NR NR Hair - Non-Coloring NR NR NR NR NR NR NR NR 2 1 3 3 Hair-Coloring NR NR NR NR NR NR NR NR NR NR 2 NR Nail NR NR NR NR NR NR NR NR NR NR NR NR Mucous Membrane 1 NR NR NR NR NR NR NR 7 7 0.3-2 ≤2 Baby Products NR NR NR NR NR NR NR NR NR NR NR NR

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Table 8. Frequency and concentration of use (historical and current) according to duration and type of exposure # of Uses Max Conc of Use (%) # of Uses Max Conc of Use (%) # of Uses Max Conc of Use (%) Tetradecyloctadecyl Stearate Tridecyl Isononanoate Tridecyl Neopentanoate 201238 201239 201238 200919 201239 200919 201238 201239 Totals 1 NR 1 1 NR 9 16 2-41 Duration of Use Leave-On 1 NR 1 1 NR 9 15 2-41 Rinse Off NR NR NR NR NR NR 1 5 Diluted for (Bath) Use NR NR NR NR NR NR NR NR Exposure Type Eye Area NR NR NR NR NR NR 10 5-41 Incidental Ingestion NR NR NR NR NR NR 2 2.5 Incidental Inhalation-Spray NR NR NR NR NR NR NR NR Incidental Inhalation-Powder NR NR NR NR NR NR NR 5 Dermal Contact 1 NR 1 1 NR 9 14 2-41 Deodorant (underarm) NR NR NR NR NR NR NR NR Hair - Non-Coloring NR NR NR NR NR NR NR NR Hair-Coloring NR NR NR NR NR NR NR NR Nail NR NR NR NR NR NR NR NR Mucous Membrane NR NR NR NR NR NR 2 2-5 Baby Products NR NR NR NR NR NR NR NR Tridecyl Stearate 201238 201239 Totals 85 0.2-18 Duration of Use Leave-On 69 0.2-16 Rinse Off 15 2-18 Diluted for (Bath) Use 1 NR Exposure Type Eye Area NR 0.3 Incidental Ingestion 10 3-16 Incidental Inhalation-Spray 1a 2 0.4 (pump spray) Incidental Inhalation-Powder 1 NR Dermal Contact 68 0.2-18 Deodorant (underarm) NR NR Hair - Non-Coloring 7 0.4-7 Hair-Coloring NR NR Nail NR NR Mucous Membrane 11 3-16 Baby Products 1 NR

*Because each ingredient may be used in cosmetics with multiple exposure types, the sum of all exposure types may not equal the sum of total uses. #Prior to 2012, concentration of use surveys did not request specific information about whether or not products are sprays. aIncludes suntan products, in that it is now known whether or not the reported product is a spray. bIt is not known whether or not the product is a spray. cProduct categories generic, giving no indication of duration of use or exposure type. NR – no reported uses NS – not specified

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Table 9. Ingredients not reported to be in current use Arachidyl Erucate Decyl Myristate Isopropyl Behenate Batyl Isostearate Decyl Palmitate Isopropyl Laurate Batyl Stearate Decyltetradecyl Cetearate Isopropyl Oleate Behenyl Isostearate Ethylhexyl Adipate/Palmitate/Stearate Isopropyl Sorbate Behenyl/Isostearyl Beeswax Ethylhexyl C10-40 Isoalkyl Acidate Isopropyl Tallowate Butyl Babassuate Ethylhexyl Neopentanoate Isostearyl Erucate Butyl Isostearate Ethylhexyl Oleate Isotridecyl Laurate Butyl Oleate Erucyl Arachidate Isotridecyl Myristate Butyloctyl Beeswax Erucyl Erucate Lauryl Behenate Butyloctyl Behenate Erucyl Oleate Lauryl Cocoate Butyloctyl Candelillate Hexyldecyl Hexyldecanoate Lauryl Isostearate Butyloctyl Cetearate Hexyldecyl Oleate Lauryl Myristate Butyloctyl Oleate Hexyldecyl Palmitate Lauryl Oleate Butyloctyl Palmitate Hexyldodecyl/Octyldecyl Hydroxystearate Lauryl Stearate C14-30 Alkyl Beeswax Hydrogenated Castor Oil Behenyl Esters Lignoceryl Erucate C18-38 Alkyl Beeswax Hydrogenated Castor Oil Cetyl Esters Myristyl Isostearate C30-50 Alkyl Beeswax Hydrogenated Castor Oil Stearyl Esters Octyldecyl Oleate C20-40 Alkyl Behenate Hydrogenated Ethylhexyl Sesamate Octyldodecyl Avocadoate C18-38 Alkyl C24-54 Acid Ester Hydrogenated Isocetyl Olivate Octyldodecyl Beeswax C16-36 Alkyl Stearate Hydrogenated Isopropyl Jojobate Octyldodecyl Behenate C30-50 Alkyl Stearate Hydroxycetyl Isostearate Octyldodecyl Cocoate C40-60 Alkyl Stearate Isobutyl Myristate Octyldodecyl Hydroxystearate Caprylyl Butyrate Isobutyl Palmitate Octyldodecyl Meadowfoamate Cetearyl Nonanoate Isobutyl Pelargonate Octyldodecyl Neodecanoate Cetearyl Palmate Isobutyl Stearate Octyldodecyl Oleate Cetearyl Palmitate Isobutyl Tallowate Octyldodecyl Safflowerate Cetearyl Rice Branate Isocetyl Behenate Oleyl Arachidate Cetyl Behenate Isocetyl Isodecanoate Oleyl Myristate Cetyl Dimethyloctanoate Isocetyl Isostearate Oleyl Stearate Cetyl Isononanoate Isocetyl Laurate Stearyl Behenate Cetyl Myristoleate Isodecyl Hydroxystearate Stearyl Erucate Cetyl Oleate Isodecyl Palmitate Stearyl Linoleate Chimyl Isostearate Isodecyl Stearate Tetradecyleicosyl Stearate Chimyl Stearate Isohexyl Laurate Tetradecyloctadecyl Behenate C10-40 Isoalkyl Acid Octyldodecanol Esters Isohexyl Neopentanoate Tetradecyloctadecyl Hexyldecanoate C4-5 Isoalkyl Cocoate Isohexyl Palmitate Tetradecyloctadecyl Myristate C32-36 Isoalkyl Stearate Isolauryl Behenate Tetradecylpropionates Coco-Rapeseedate Isooctyl Caprylate/Caprate Tridecyl Behenate Decyl Castorate Isooctyl Tallate Tridecyl Cocoate Decyl Isostearate Isopropyl Arachidate Tridecyl Erucate Decyl Jojobate Isopropyl Avocadate Tridecyl Laurate Decyl Laurate Isopropyl Babassuate Tridecyl Myristate

Table 10. Examples of non-cosmetic uses Ingredient Non-Cosmetic Use Reference Behenyl Behenate used in mold releasing agents in methyl acrylamide polymer 74 Butyl Oleate indirect food additive as a plasticizer in rubber articles 21CFR177.2600 biodiesel additive; polyvinylchloride plasticizer; water-resisting agent; in hydraulic fluids 91 Ethylhexyl Laurate lubricant for friction and in paper industry; activity enhancer for pesticides 75 Isoamyl Laurate direct food additive as a synthetic flavoring substance and adjuvant 21CFR172.515 Isobutyl Palmitate indirect food additive used in fiber finishing or in textile fibers 21CFR177.2260; 21CFR177.2800 Isooctyl Tallate indirect food additive as a plasticizer in rubber articles 21CFR177.2600 Isopropyl Laurate indirect food additive as a lubricant in the manufacture of metallic articles; use level not to exceed 21CFR178.3910 10% by wt. Isopropyl Oleate indirect food additive as a lubricant in the manufacture of metallic articles or in mineral oil 21CFR178.3910; lubricants with incidental food contact 21CFR178.3570

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Table 11. Irritation and sensitization studies Test Article Concentration/Dose Test Population Procedure Results Reference DERMAL IRRITATION NON-HUMAN Propylheptyl Caprylate propylheptyl caprylate applied neat; amount ap- SPF albino rabbits, 4-h semi-occlusive patch; man scores were calculated on the moderately irritating 56 plied was not specified 3 females bases of 24, 48, and 72-h scores, with a maximum value of 3 erythema: scores were 2, 2, and 2.33 edema: scores were 0.33, 1, and 0 Isopropyl Palmitate

cream formulation consisting of 5 mg cream/cm2 applied hairless guinea pigs, tolerance test; open applications were made on each side of cream with 10% isopropyl palmitate, but not with- 50 10% isopropyl palmitate, 2x/day 15 males the dorsal trunk for 4 days; test sites were scored immediately out it, caused a moderate degree of irritation carbomers, sorbitan oleate, prior to each application and at the end of the study on scale the clinical scores as assessed by the AUC (given paraffin liquid, propylene of 0-4 for erythema and 0-3 for both scaling and fissures for a as the mean; study days were plotted on the x-axis glycol, trometamol, and purified total possible score of 10 and average clinical score on the y-axis) were 1.10, water cream without isopropyl palmitate served as the negative 7.25, and 9.10 for the negative control, the cream vehicle control; cream consisting of glyceryl stearate, PEG- containing isopropyl palmitate, and the positive 100 stearate, cetostearyl alcohol, paraffin oil, propylene control, respectively glycol, citric acid monohydrate, sodium citrate was used as a positive vehicle control Ethylhexyl Laurate ethylhexyl laurate 0.5 g rabbits, number not OECD Guideline 404 for “acute dermal irritation/corrosion” slightly irritating using OECD guidelines 57 specified testing: a semi-occlusive patch is applied to an approximately non-irritating according to the EC classification 6 cm2area for 4 h; erythema and edema are each scored on a scale of 0-4 Isodecyl Laurate isodecyl laurate 30 in liquid paraffin unclear whether rats applications were made to two 4 cm x 4 cm intact and abraded not irritating 58 500 mg/dose or rabbits were used test sites; details were not provided HUMAN Propylheptyl Caprylate propylheptyl caprylate undiluted and 10, 25, or 22 subjects single 48-h occlusive application ; approximately 0.2 ml of no dermal effects at any concentration 56 50% in mineral oil each test material was applied using a 1.9 cm x 1.9 cm patch 47.6 mg/cm2 Isopropyl Myristate isopropyl myristate not specified 244 subjects with patch testing occurred over a 3-yr period with a series of test three positive responses to isopropyl myristate 59 contact dermatitis materials (details were not provided) Isopropyl Palmitate cream containing 10% isopropyl 0.1 ml 20 subjects human chamber scarification test; occlusive 23-h patch; test the test material was well-tolerated 50 palmitate (described earlier) material was applied to the abraded skin of the volar forearm clinical scores for the test material (2.71), the daily for 3 days positive vehicle control (2.51), and the negative paraffin oil was applied as the negative control and 0.5% aq. vehicle control (2.39) as assessed by AUC (given SLS was used as the positive control; positive and negative as the geomean; study days were plotted on the x- vehicle control creams (described previously) were also tested axis and average clinical score on the y-axis) were irritation was scored on a scale of 0-4 immediately prior to greater than that of the negative control (2.17), but patch application and 1 h after removal of the final patch the differences were not statistically significant clinical score of the positive control was 5.29

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Table 11. Irritation and sensitization studies Test Article Concentration/Dose Test Population Procedure Results Reference Ethylhexyl Laurate 2-ethylhexyl esters of C8-14 50% and undiluted 10 subjects open epicutaneous test; test substance was applied for 60 min not irritating at either concentration 57 fatty acids (additional details were not provided.) 2-ethylhexyl esters of C8-14 25, 50,and 100% 20 subjects closed epicutaneous test; applied for 24 h under an occlusive 25 and 50%: no reactions observed 57 fatty acids patch (additional details were not provided.) 100%: slight erythema, 3 incidences of moderate edema, and 1 of slight edema were observed DERMAL SENSITIZATION NON-HUMAN Propylheptyl Caprylate propylheptyl caprylate 0, 2, 10, and 50% in corn mouse LLNA not a sensitizer 56 oil a lymphocyte proliferative response was not induced Ethylhexyl Laurate ethylhexyl laurate intradermal induction: 0.5% guinea pigs GPMT (details were not provided) not a sensitizer 57 topical induction: 40% challenge: 20% Isodecyl Laurate isodecyl laurate not specified guinea pigs GPMT (details were not provided) not a sensitizer 58 HUMAN Butyl Oleate butyl oleate not specified 25 subjects; 9 male maximization study; an occlusive patch was applied to the not a sensitizer 60 and 16 female volar forearm of all subjects for 5 alternate-day 48-h periods all challenge scores were 0 an occlusive patch wit h 5% SLS was applied prior to patching sites were scored upon patch removal and 24 h later Ethylhexyl Palmitate body oil containing 77.9% applied neat 104 subjects modified HRIPT; 24-h semi-occlusive patches with 150 µl of not an irritant or a sensitizer 61 ethylhexyl palmitate test material no reactions were observed during induction or induction: 2 cm x 2 cm Webril pad was applied for 24-h, challenge 3x/wk for 3 wks; sites were graded 24 or 48 h after patch removal challenge: after a 1-wk non-treatment period, two concurrent 24-h challenge patches were applied, one to the induction site and one to a previously untreated area on the back; these sites were graded immediately upon and 24 h after patch removal Ethylhexyl Stearate lip gloss formulation containing applied neat 104 subjects modified HRIPT; 24-h semi-occlusive patches with 150 mg of not an irritant or a sensitizer 62 25.9% ethylhexyl stearate test material no reactions were observed during induction or induction: 2 cm x 2 cm Webril pad was applied for 24-h, challenge 3x/wk for 3 wks; sites were graded 24 or 48 h after patch removal challenge: after a 1-wk non-treatment period, two concurrent 24-h challenge patches were applied, one to the induction site and one to a previously untreated area on the back; these sites were graded immediately upon and 24 h after patch removal

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Table 11. Irritation and sensitization studies Test Article Concentration/Dose Test Population Procedure Results Reference eyebrow pencil formulation applied neat 642 subjects HRIPT; 24-h semi-occlusive patches not an irritant or a sensitizer 63 containing 38.8% ethylhexyl induction: patches applied 3x/wk for 3 wks; sites were graded no reactions were observed during induction or stearate for irritation 24 or 48 h after patch removal challenge challenge: after a 2-wk non-treatment period, a 24-h challenge patch was applied to a previously untreated area on the back; this site was graded upon patch removal and at 48 and 72 h Isocetyl Myristate concealer formulation contain- applied neat 104 subjects HRIPT; 24-h semi-occlusive patches; 0.2 g test material not an irritant or a sensitizer 64 ing 29.5% isocetyl myristate induction: 1” x 1” absorbent pad with clear adhesive dressing no reactions were observed during induction or was applied 3x/wk for 3 wks; sites were graded for irritation challenge 24 or 48 h after patch removal challenge: after a 2-wk non-treatment period, a 24-h challenge patch was applied to a previously untreated area on the back; this site was graded upon patch removal and at 72 h Cetyl Ricinoleate lipstick formulation containing applied neat 621 subjects HRIPT;24-h semi-occlusive patches not an irritant or a sensitizer 65 15.2% cetyl ricinoleate induction: patches applied 3x/wk for 3 wks; sites were graded no reactions were observed during induction or for irritation 24 or 48 h after patch removal challenge challenge: after a 2-wk non-treatment period, a 24-h chal- lenge patch was applied to a previously untreated area on the back; this site was graded upon patch removal and at 48 and 72 h

Abbreviations: AUC = area under the curve; EC = European Commission; GPMT – guinea pig maximization test; HRIPT = human repeated insult patch test; LLNA = local lymph node assay; OECD = Organisation for Economic Co-operation and Development; SLS = sodium lauryl sulfate

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